§262. Regulation of biological products — Inbound Citations

42 U.S.C. § 262

Cited by 313 provisions in release 119-102.

Citations to 42 U.S.C. § 262 as a whole

7 U.S.C. § 1639r(c)(2)

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(2) section 262 of title 42; or
7 U.S.C. § 1639r(c)(3)(A)(ii)

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(ii) section 262 of title 42; or
7 U.S.C. § 8401(g)(1)(C)(ii)(II)

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(II) Section 351 of the Public Health Service Act [42 U.S.C. 262].
10 U.S.C. § 1110(a)(1)(C)

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(C) Each refusal by such a member of any vaccine that is being so administered, including vaccines licensed by the Food and Drug Administration under section 351 of the Public Health Service Act (42 U.S.C. 262) and vaccines otherwise approved or authorized.
21 U.S.C. § 321(dd)

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(dd) For purposes of sections 335a and 335b of this title, the term “drug product” means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42.
21 U.S.C. § 321(ff)(3)(A)

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(A) include an article that is approved as a new drug under section 355 of this title or licensed as a biologic under section 262 of title 42 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this title; and
21 U.S.C. § 321(ff)(3)(B)(i)

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(i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
21 U.S.C. § 331(ll)

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(ll) The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title, a biological product licensed under section 262 of title 42, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—

(1) such drug or such biological product was marketed in food before any approval of the drug under section 355 of this title, before licensure of the biological product under such section 262 of title 42, and before any substantial clinical investigations involving the drug or the biological product have been instituted;

(2) the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food;

(3) the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—

(A) a regulation issued under section 348 of this title prescribing conditions of safe use in food;

(B) a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;

(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier’s determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;

(D) a food contact substance notification that is effective under section 348(h) of this title; or

(E) such drug or biological product had been marketed for smoking cessation prior to September 27, 2007; or

(4) the drug is a new animal drug whose use is not unsafe under section 360b of this title.
21 U.S.C. § 331(ll)(1)

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(1) such drug or such biological product was marketed in food before any approval of the drug under section 355 of this title, before licensure of the biological product under such section 262 of title 42, and before any substantial clinical investigations involving the drug or the biological product have been instituted;
21 U.S.C. § 333(g)(1)

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(1) With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.
21 U.S.C. § 352(a)(1)

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(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42. The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.
21 U.S.C. § 352(a)(2)(B)

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(B) Such term does not include any analysis that relates only to an indication that is not approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device.
21 U.S.C. § 352(gg)(1)

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(1) Unless its labeling bears adequate directions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such paragraph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable), provided—

(A) the product information includes—

(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established;

(ii) information related to the stage of development of the drug or device involved, such as—

(I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated;

(II) how the study or studies relate to the overall plan for the development of the drug or device; and

(III) whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned;

(iii) in the case of information that includes factual presentations of results from studies, which shall not be selectively presented, a description of—

(I) all material aspects of study design, methodology, and results; and

(II) all material limitations related to the study design, methodology, and results;

(iv) where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42, and a copy of the most current required labeling; and

(v) updated information, if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and

(B) the product information does not include—

(i) information that represents that an unapproved product—

(I) has been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable); or

(II) has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied; or

(ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing authorization, cleared, or licensed—

(I) is so approved, granted marketing authorization, cleared, or licensed; or

(II) that the product is safe or effective for the use or uses for which the drug or device is being studied.
21 U.S.C. § 352(gg)(1)(A)(i)

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(i) a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable) and that the safety and effectiveness of such drug or device for such use has not been established;
21 U.S.C. § 352(gg)(1)(A)(iv)

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(iv) where applicable, a prominent statement disclosing the indication or indications for which the Secretary has approved, granted marketing authorization, cleared, or licensed the product pursuant to section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42, and a copy of the most current required labeling; and
21 U.S.C. § 352(gg)(1)(B)(i)(I)

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(I) has been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable); or
21 U.S.C. § 352(gg)(2)(C)

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(C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355, 360(k), 360c, or 360e of this title or section 262 of title 42;
21 U.S.C. § 353(iii)(9)(C)(iii)

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(iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262); and
21 U.S.C. § 353(iii)(9)(D)

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(D) The terms “premarket review” and “reviews” include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [42 U.S.C. 262], including with respect to investigational use of the product.
21 U.S.C. § 353c(e)(2)

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(2) In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 355 of this title or section 262 of title 42, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.
21 U.S.C. § 355(b)(5)(A)

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(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1) or under section 262 of title 42, which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.
21 U.S.C. § 355(b)(5)(B)

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(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection or section 262 of title 42 if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size—

(I) of clinical trials intended to form the primary basis of an effectiveness claim; or

(II) in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or

(ii) with respect to an application for approval of a biological product under section 262(k) of title 42, of any necessary clinical study or studies.

The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of the clinical trials. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request.
21 U.S.C. § 355(b)(5)(G)

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(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection or section 262 of title 42 (including all scientific and medical matters, chemistry, manufacturing, and controls).
21 U.S.C. § 355(k)(3)(A)

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(A) In this paragraph, the term “data” refers to information with respect to a drug approved under this section or under section 262 of title 42, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary.
21 U.S.C. § 355(l)(2)(A)

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(A) The Secretary shall publish the action package for approval of an application under subsection (b) or section 262 of title 42 on the Internet Web site of the Food and Drug Administration—

(i) not later than 30 days after the date of approval of such applications—

(I) for a drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under this section; or

(II) for a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42; and

(ii) not later than 30 days after the third request for such action package for approval received under section 552 of title 5 for any other drug or biological product.
21 U.S.C. § 355(l)(2)(A)(i)(II)

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(II) for a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42; and
21 U.S.C. § 355(n)(1)

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(1) For the purpose of providing expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug under this section or section 262 of title 42, the Secretary shall establish panels of experts or use panels of experts established before November 21, 1997, or both.
21 U.S.C. § 355(o)(2)(B)(ii)

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(ii) an application under section 262 of title 42.
21 U.S.C. § 355(p)(1)(A)(ii)

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(ii) the application for such drug is approved under section 262 of title 42; and
21 U.S.C. § 355(r)(1)(A)

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(A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are approved under this section or licensed under section 262 of title 42; and
21 U.S.C. § 355(r)(2)(D)

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(D) preparing and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or section 262 of title 42;
21 U.S.C. § 355(s)(1)(B)

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(B) a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42; or
21 U.S.C. § 355a(n)(1)(A)

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(A) For a drug for which a listed patent has not expired, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended, make a determination regarding whether an assessment shall be required to be submitted under section 355c(b) of this title.
21 U.S.C. § 355a(n)(1)(B)

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(B) For a drug that has no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply, the Secretary shall refer the drug for inclusion on the list established under section 284m of title 42 for the conduct of studies.
21 U.S.C. § 355c(a)(1)(A)(ii)

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(ii) under section 262 of title 42 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration,
21 U.S.C. § 355c(a)(1)(B)

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(B) A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under section 355 of this title or section 262 of title 42, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—

(i) intended for the treatment of an adult cancer; and

(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
21 U.S.C. § 355c(a)(2)(B)(iii)

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(iii) A brief documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be included in any pertinent reviews for the application under section 355 of this title or section 262 of title 42.
21 U.S.C. § 355c(b)(1)

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(1) The Secretary may (by order in the form of a letter) require the sponsor or holder of an approved application for a drug under section 355 of this title or the holder of a license for a biological product under section 262 of title 42 to submit by a specified date the assessments described in subsection (a)(2), if the Secretary finds that—

(i) the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and

(ii) adequate pediatric labeling could confer a benefit on pediatric patients;

(B) there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients for 1 or more of the claimed indications; or

(C) the absence of adequate pediatric labeling could pose a risk to pediatric patients.
21 U.S.C. § 355c(d)(2)(B)

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(B) to revoke the license for a biological product under section 262 of title 42.
21 U.S.C. § 355c(l)(1)

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(1) A biological product that is biosimilar to a reference product under section 262 of title 42, and that the Secretary has not determined to meet the standards described in subsection (k)(4) of such section for interchangeability with the reference product, shall be considered to have a new active ingredient under this section.
21 U.S.C. § 355c(l)(2)

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(2) A biological product that is interchangeable with a reference product under section 262 of title 42 shall not be considered to have a new active ingredient under this section.
21 U.S.C. § 355–1(g)(2)(A)

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(A) when submitting a supplemental application for a new indication for use under section 355(b) of this title or under section 262 of title 42, unless the drug is not subject to section 353(b) of this title and the risk evaluation and mitigation strategy for the drug includes only the timetable under subsection (d);
21 U.S.C. § 355–2(a)(2)(A)(i)

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(i) any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42;
21 U.S.C. § 355–2(a)(2)(A)(iii)

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(iii) when reasonably necessary to support approval of an application under section 355 of this title, or section 262 of title 42, as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and
21 U.S.C. § 355–2(a)(5)

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(5) the term “license holder” means the holder of an application approved under subsection (c) or (j) of section 355 of this title or the holder of a license under subsection (a) or (k) of section 262 of title 42 for a covered product;
21 U.S.C. § 356(h)(1)(B)

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(B) the standards for approval under section 355(c) and (d) of this title, or the standards for licensure under section 351 of the Public Health Service Act [42 U.S.C. 262], as applicable, are met; and
21 U.S.C. § 356(h)(8)

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(8) Nothing in this subsection shall be construed to alter the authority of the Secretary to approve drugs pursuant to this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262], including the standards of evidence and applicable conditions for approval under such chapter or Act, the standards of approval of a drug under such chapter or Act, or to alter the authority of the Secretary to monitor drugs pursuant to such chapter or Act.
21 U.S.C. § 356a(a)

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(a) With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under section 262 of title 42, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if—

(1) the holder of the approved application or license (referred to in this section as a “holder”) has validated the effects of the change in accordance with subsection (b); and

(A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or

(B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d).
21 U.S.C. § 356c(h)(1)(B)

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(B) does not include biological products (as defined in section 262 of title 42), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);
21 U.S.C. § 356c(i)(3)(A)

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(A) The Secretary may by regulation apply this section to biological products (as defined in section 262 of title 42), including plasma products derived from human plasma protein and their recombinant analogs, if the Secretary determines such inclusion would benefit the public health. Such regulation shall take into account any supply reporting programs and shall aim to reduce duplicative notification.
21 U.S.C. § 356i(a)

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(a) The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—

(1) National Drug Code;

(2) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(3) new drug application number, abbreviated application number, or biologics license application number;

(4) strength of the drug;

(5) date on which the drug is expected to no longer be available for sale; and

(6) reason for withdrawal of the drug.
21 U.S.C. § 356i(b)

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(b) The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—

(1) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(2) new drug application number, abbreviated application number, or biologics license application number;

(3) strength of the drug;

(4) date on which the drug will be available for sale, if known; and

(5) reason for not marketing the drug after approval.
21 U.S.C. § 356i(c)

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(c) Within 180 days of December 29, 2022, all holders of applications approved under subsection (a) or (k) of section 262 of title 42 shall review the information in the list published under section 262(k)(9)(A) of title 42 and shall submit a written notice to the Secretary—

(1) stating that all of the application holder’s biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or

(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale.
21 U.S.C. § 356k(b)(1)

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(1) the platform technology is incorporated in, or utilized by, a drug approved under section 355 of this title or a biological product licensed under section 351 of the Public Health Service Act [42 U.S.C. 262];
21 U.S.C. § 356k(i)(1)

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(1) alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act [21 U.S.C. 355] or license biological products pursuant to section 351 of the Public Health Service Act [42 U.S.C. 262], including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or
21 U.S.C. § 356l(d)(1)

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(1) expedite the development and review of an application submitted under section 355 of this title or section 262 of title 42, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and
21 U.S.C. § 356l(d)(2)

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(2) allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 355 of this title or section 262 of title 42, including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted.
21 U.S.C. § 356l(e)(3)(E)

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(E) The number of applications received under section 355 of this title or section 262 of title 42, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved.
21 U.S.C. § 356–1(b)

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(b) A drug for which approval is sought under section 355(b) of this title or section 262 of title 42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123¹ may be designated as a fast track product for purposes of this section.
21 U.S.C. § 357(b)(2)(A)

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(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or
21 U.S.C. § 357(c)(1)(E)(ii)

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(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 357(c)(3)(A)(i)

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(i) any information contained in an application submitted under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5 or section 1905 of title 18; or
21 U.S.C. § 357(d)(1)

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(1) to alter the standards of evidence under subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable); or
21 U.S.C. § 360(h)(6)(A)(iv)

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(iv) the number of inspections to support actions by the Secretary on applications under section 355 of this title or section 262 of title 42, including the number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year;
21 U.S.C. § 360(j)(3)(B)

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(B) By order of the Secretary, certain biological products or categories of biological products regulated under section 262 of title 42 may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines that applying such reporting requirements to such biological products or categories of biological products is not necessary to protect the public health.
21 U.S.C. § 360aa(a)

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(a) The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—

(1) it may be approved for such disease or condition under section 355 of this title, or

(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.

If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 355 of this title or licensing of such drug for such disease or condition under section 262 of title 42.
21 U.S.C. § 360aa(a)(2)

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(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.
21 U.S.C. § 360a–2(a)(2)(A)

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(A) if such criteria are available on the date of approval of the drug under section 355 of this title or licensure of the drug under section 262 of title 42 (as applicable), upon such approval or licensure; or
21 U.S.C. § 360a–2(b)(2)(B)(iii)

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(iii) the Secretary approves an application under section 355 of this title or section 262 of title 42, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or
21 U.S.C. § 360a–2(c)(1)(B)

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(B) Upon the approval of an initial or supplemental application for an antimicrobial drug under section 355 of this title or section 262 of title 42, as applicable, where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to this subsection, or for which there are no relevant interpretive criteria standards recognized, or interpretive criteria otherwise listed, by the Secretary pursuant to this subsection, the Secretary shall update the lists under subparagraphs (A) and (B) of subsection (b)(2) to include the susceptibility test interpretive criteria upon which such approval was based.
21 U.S.C. § 360a–2(d)(1)(A)

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(A) With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 355 of this title or section 262 of title 42, as applicable, for each such drug, not later than 1 year after establishment of the Interpretive Criteria Website described in subsection (b)(1), shall remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website.
21 U.S.C. § 360a–2(f)(4)(B)(ii)

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(ii) biological products (as such term is defined in section 262 of title 42) to the extent such products exhibit antimicrobial activity.
21 U.S.C. § 360a–2(g)(1)

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(1) alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard under section 355(d) of this title) or under section 262 of title 42 (as applicable); or
21 U.S.C. § 360bb(a)(1)

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(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—

(A) if an application for such drug is approved under section 355 of this title, or

(B) if a license for such drug is issued under section 262 of title 42,

the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b)¹ respecting the designation of the drug.
21 U.S.C. § 360bb(a)(1)(B)

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(B) if a license for such drug is issued under section 262 of title 42,
21 U.S.C. § 360bb(b)(1)

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(1) if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and
21 U.S.C. § 360bb(b)(2)

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(2) if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 355(b) of this title or approval of a license under section 262 of title 42.
21 U.S.C. § 360bbb–0a(a)(2)(B)

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(B) that has not been approved or licensed for any use under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262];
21 U.S.C. § 360bbb–0a(a)(2)(C)(ii)(I)

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(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; and
21 U.S.C. § 360bbb–0a(c)(1)

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(1) Notwithstanding any other provision of this chapter, the Public Health Service Act [42 U.S.C. 201 et seq.], or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] unless—

(A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or

(B) the sponsor requests use of such outcomes.
21 U.S.C. § 360bbb–0a(d)(2)(C)

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(C) not used in the review of an application under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360bbb–1

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If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in section 355(n) of this title or an advisory committee described in section 360e(g)(2)(B) of this title. Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after November 21, 1997.
21 U.S.C. § 360bbb–3(a)(1)

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(1) Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).
21 U.S.C. § 360bbb–3(a)(2)(A)

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(A) is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title (referred to in this section as an “unapproved product”); or
21 U.S.C. § 360bbb–3(a)(4)(A)

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(A) The term “biological product” has the meaning given such term in section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360bbb–3(c)(2)(A)(ii)

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(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
21 U.S.C. § 360bbb–3(k)

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(k) If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360bbb–3(l)

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(l) Nothing in this section provides the Secretary any authority to require any person to carry out any activity that becomes lawful pursuant to an authorization under this section, and no person is required to inform the Secretary that the person will not be carrying out such activity, except that a manufacturer of a sole-source unapproved product authorized for emergency use shall report to the Secretary within a reasonable period of time after the issuance by the Secretary of such authorization if such manufacturer does not intend to carry out any activity under the authorization. This section only has legal effect on a person who carries out an activity for which an authorization under this section is issued. This section does not modify or affect activities carried out pursuant to other provisions of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262]. Nothing in this subsection may be construed as restricting the Secretary from imposing conditions on persons who carry out any activity pursuant to an authorization under this section.
21 U.S.C. § 360bbb–3a(a)(1)(A)

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(A) is approved or cleared under this subchapter, conditionally approved under section 360ccc of this title, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262];
21 U.S.C. § 360bbb–3b(2)(A)

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(A) is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;
21 U.S.C. § 360bbb–3b(2)(B)

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(B) is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or
21 U.S.C. § 360bbb–3c(1)

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(1) The Secretary of Defense may request that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, take actions to expedite the development of a medical product, review of investigational new drug applications under section 355(i) of this title, review of investigational device exemptions under section 360j(g) of this title, and review of applications for approval and clearance of medical products under sections 355, 360(k), and 360e of this title and section 262 of title 42, including applications for licensing of vaccines or blood as biological products under such section 262 of title 42, or applications for review of regenerative medicine advanced therapy products under section 356(g) of this title, if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical product that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk.
21 U.S.C. § 360bbb–3c(4)

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(4) In this subsection, the term “medical product” means a drug (as defined in section 321 of this title), a device (as defined in such section 321 of this title), or a biological product (as defined in section 262 of title 42).
21 U.S.C. § 360bbb–4(h)(1)

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(1) The Secretary may, at the request of the sponsor of a countermeasure, during a domestic, military, or public health emergency or material threat described in section 360bbb–3a(a)(1)(C) of this title, expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or section 262 of title 42.
21 U.S.C. § 360bbb–4a(a)(4)(D)(ii)

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(ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360bbb–4b(d)(2)

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(2) If the Secretary has reviewed and relied upon specified data or information within a medical countermeasure master file to support the conditional approval of an application under section 360ccc of this title to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, the Secretary shall provide a brief written description to the master file holder regarding the elements of the application fulfilled by the data or information within the master file and how such data or information contained in such application meets the standards of evidence under subsection (c) or (d) of section 355 of this title, subsection (d) of section 360b of this title, or section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable), which shall not include any trade secret or confidential commercial information.
21 U.S.C. § 360bbb–4b(e)(1)

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(1) limit the authority of the Secretary to approve, license, clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to, as applicable, this Act [this chapter] or section 351 of the Public Health Service Act [42 U.S.C. 262] (as such applicable Act is in effect on the day before June 24, 2019), including the standards of evidence, and applicable conditions, for approval under the applicable Act;
21 U.S.C. § 360bbb–4b(e)(2)

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(2) alter the standards of evidence with respect to approval, licensure, or clearance, as applicable, of drugs, biological products, or devices under this Act [this chapter] or section 351 of the Public Health Service Act [42 U.S.C. 262], including, as applicable, the substantial evidence standards under sections 355(d) and 360b(d) of this title and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or
21 U.S.C. § 360bbb–4b(e)(3)

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(3) alter the authority of the Secretary under this Act [this chapter] or the Public Health Service Act [42 U.S.C. 201 et seq.] to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 355(i), 355(b), 355(j), 360b(b)(1), 360b(b)(2), 360b(j), 360bbb–3, 360ccc, 360j(g), 360e(c), 360c(f)(2), or 360(k) of this title, or subsection (a) or (k) of section 351 of the Public Health Service Act [42 U.S.C. 262], including a supplement or amendment to any such submission, and the requirements associated with such reference.
21 U.S.C. § 360bbb–5(e)

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(e) In this section, the term “medical product” includes a drug, a biological product as defined in section 262 of title 42, a device, and any combination of such products.
21 U.S.C. § 360bbb–8(g)(1)

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(1) Prior to a consultation with an external expert, as described in this section, relating to an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or a biologics license application under section 262 of title 42, the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or appropriate Division Director), as appropriate, shall determine that—

(A) such consultation will—

(i) facilitate the Secretary’s ability to complete the Secretary’s review; and

(ii) address outstanding deficiencies in the application; or

(B) the sponsor authorized such consultation.
21 U.S.C. § 360cc(a)

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(a) Except as provided in subsection (b), if the Secretary—

(1) approves an application filed pursuant to section 355 of this title, or

(2) issues a license under section 262 of title 42

for a drug designated under section 360bb of this title for a rare disease or condition, the Secretary may not approve another application under section 355 of this title or issue another license under section 262 of title 42 for the same drug for the same approved use or indication within such rare disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2)¹ of this title does not apply to the refusal to approve an application under the preceding sentence.
21 U.S.C. § 360cc(a)(2)

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(2) issues a license under section 262 of title 42
21 U.S.C. § 360cc(b)

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(b) During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same approved use or indication for which such 7-year period applies to such already approved or licensed drug if—

(1) the Secretary finds, after providing the holder of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure the availability of sufficient quantities of the drug to meet the needs, relating to the approved use or indication, of persons with the disease or condition for which the drug was designated; or

(2) the holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period.
21 U.S.C. § 360cc(c)(3)

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(3) This subsection applies to any drug designated under section 360bb of this title for which an application was approved under section 355 of this title or licensed under section 262 of title 42 after August 18, 2017, regardless of the date on which such drug was designated under section 360bb of this title.
21 U.S.C. § 360cc(f)

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(f) In this section, the term “approved use or indication” means the use or indication approved under section 355 of this title or licensed under section 262 of title 42 for a drug designated under section 360bb of this title for a rare disease or condition.
21 U.S.C. § 360ee(b)(1)(A)(ii)

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(ii) which occurs before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 of title 42;
21 U.S.C. § 360ee(b)(1)(B)

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(B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under section 360bb of this title and before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 of title 42; and
21 U.S.C. § 360eee(10)(A)

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(A) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;
21 U.S.C. § 360eee(24)(B)(xii)

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(xii) a combination product that is not subject to approval under section 355 of this title or licensure under section 262 of title 42, and that is—

(I) a product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(II) 2 or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or

(III) 2 or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a “medical convenience kit” as described in clause (xiii);
21 U.S.C. § 360eee(24)(B)(xviii)

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(xviii) the distribution or sale of any licensed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title.
21 U.S.C. § 360ff(e)(1)

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(1) The Secretary may revoke any priority review voucher awarded under subsection (b) if the rare pediatric disease product for which such voucher was awarded is not marketed in the United States within the 365-day period beginning on the date of the approval of such drug under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360ff(i)(1)(B)(i)

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(i) The indications for which each rare disease product for which a priority review voucher was awarded was approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360fff–4(b)(4)

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(4) Nothing in this part shall affect the marketing of a drug approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].
21 U.S.C. § 360ff–1(d)(1)

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(1) alter the authority of the Secretary to approve drugs pursuant to this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262] (as authorized prior to December 13, 2016), including the standards of evidence, and applicable conditions, for approval under such applicable chapter or Act; or
21 U.S.C. § 360j(p)(2)(B)

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(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 355 of this title or section 262 of title 42, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection.
21 U.S.C. § 360j(p)(4)(B)

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(B) the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—

(i) is a diagnostic radiopharmaceutical, as defined in section³ 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.
21 U.S.C. § 360n(a)(2)

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(2) The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 262 of title 42 after the date of approval of the tropical disease product application.
21 U.S.C. § 360n(a)(4)(C)(ii)

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(ii) a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42.
21 U.S.C. § 360n(b)(2)

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(2) The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 355(b)(1) of this title or section 262 of title 42 will be submitted after the date of the approval of the tropical disease product application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
21 U.S.C. § 360n(c)(4)(A)

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(A) The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 262 of title 42 for which the priority review voucher is used.
21 U.S.C. § 374(a)(5)(E)(iii)(I)

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(I) a drug subject to section 355 or 360b of this title or section 262 of title 42; or
21 U.S.C. § 374(g)(15)(A)(i)

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(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 262 of title 42), as required under section 360(h) of this title; or
21 U.S.C. § 379g(1)

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(1) The term “human drug application” means an application for—

(A) approval of a new drug submitted under section 355(b) of this title, or

(B) licensure of a biological product under subsection (a) of section 262 of title 42.

Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.
21 U.S.C. § 379g(1)(B)

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(B) licensure of a biological product under subsection (a) of section 262 of title 42.
21 U.S.C. § 379g(3)(A)(iii)

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(iii) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).
21 U.S.C. § 379g(3)(B)

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(B) Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.
21 U.S.C. § 379g(6)(D)

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(D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.
21 U.S.C. § 379h(k)(1)

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(1) A drug designated under section 360bb of this title for a rare disease or condition and approved under section 355 of this title or under section 262 of title 42 shall be exempt from prescription drug program fees under this section, if the drug meets all of the following conditions:

(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.

(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as determined under paragraph (2).
21 U.S.C. § 379i(1)(A)

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(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or
21 U.S.C. § 379i(4)(A)(i)

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(i) an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or
21 U.S.C. § 379i(4)(E)

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(E) The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.
21 U.S.C. § 379i(9)(E)

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(E) Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.
21 U.S.C. § 379i(9)(J)

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(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.
21 U.S.C. § 379j(a)(2)(B)(ii)

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(ii) No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.
21 U.S.C. § 379k–1(a)(1)

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(1) Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.
21 U.S.C. § 379k–1(b)(1)

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(1) Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
21 U.S.C. § 381(u)(1)(B)(i)(I)

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(I) that is approved under section 355 of this title or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262]; or
21 U.S.C. § 382(a)(1)(A)(ii)

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(ii) requires licensing by the Secretary under section 262 of title 42 or by the Secretary of Agriculture under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;
21 U.S.C. § 382(a)(2)(C)

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(C) is a banned device under section 360f of this title, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or section 381(e)(2) of this title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 355 or 360e of this title or section 262 of title 42 was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval.
21 U.S.C. § 382(h)(2)

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(2) the term “drug” includes drugs for human use as well as biologicals under section 262 of title 42 or the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act).
21 U.S.C. § 384(a)(3)(B)

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(B) a biological product (as defined in section 262 of title 42);
21 U.S.C. § 392(b)

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(b) Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [42 U.S.C. 262] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [21 U.S.C. 151 et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141 et seq.].
21 U.S.C. § 399g(a)(2)

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(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 355, 360(k), 360c(f)(2), and 360e of this title and section 262 of title 42, and other applicable authorities;
26 U.S.C. § 223(c)(2)(G)(ii)(II)

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(II) The term “insulin” means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section, including any insulin product that has been deemed to be licensed under section 351(a) of such Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) and continues to be marketed pursuant to such licensure.
42 U.S.C. § 236(c)(5)

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(5) with the consent of the sponsor of a drug for a rare disease or condition exempt under section 505(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i)] or regulations issued under such section, inform physicians and the public respecting the availability of such drug for such disease or condition and inform physicians and the public respecting the availability of drugs approved under section 505(c) of such Act [21 U.S.C. 355(c)] or licensed under section 262 of this title for rare diseases or conditions,
42 U.S.C. § 247d–6b(c)(1)(B)(i)(III)(aa)

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(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or
42 U.S.C. § 247d–6d(c)(5)(B)(i)

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(i) The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title.
42 U.S.C. § 247d–6d(c)(5)(B)(ii)(I)

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(I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal of an approval or clearance under chapter 5¹ of such Act or of a licensure under section 262 of this title; and
42 U.S.C. § 247d–6d(i)(7)(B)(i)

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(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;
42 U.S.C. § 247d–7e(a)(6)(A)(ii)

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(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title.
42 U.S.C. § 247d–7e(a)(6)(B)(i)

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(i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or under section 262 of this title for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;
42 U.S.C. § 247d–7e(c)(2)(C)

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(C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section 262 of this title; and
42 U.S.C. § 247d–7e(c)(4)(B)(iii)

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(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or section 262 of this title) and innovation in such areas as the Secretary may identify as priority unmet need areas;
42 U.S.C. § 247d–7e(c)(4)(C)(i)

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(i) connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and under section 262 of this title related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products;
42 U.S.C. § 262a(g)(2)(B)(ii)

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(ii) Section 262 of this title.
42 U.S.C. § 263(a)

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(a) The Service may prepare for its own use any product described in section 262 of this title and any product necessary to carrying out any of the purposes of section 241 of this title.
42 U.S.C. § 263(b)

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(b) The Service may prepare any product described in section 262 of this title for the use of other Federal departments or agencies, and public or private agencies and individuals engaged in work in the field of medicine when such product is not available from establishments licensed under such section.
42 U.S.C. § 263–1(a)(4)(A)

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(A) the action package of each biological product licensed under subsection (a) or (k) of section 262 of this title; or
42 U.S.C. § 263–1(a)(4)(B)

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(B) the summary review of each biological product licensed under subsection (a) or (k) of section 262 of this title.
42 U.S.C. § 282(j)(1)(A)(iii)(I)

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(I) The term “applicable drug clinical trial” means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title.
42 U.S.C. § 282(j)(1)(A)(vii)

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(vii) The term “drug” means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title.
42 U.S.C. § 282(j)(2)(A)(ii)(II)(gg)

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(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 355 of title 21 or licensed under section 262 of this title, specify whether or not there is expanded access to the drug under section 360bbb of title 21 for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;
42 U.S.C. § 282(j)(3)(C)

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(C) Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:

(i) A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.

(ii) The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

(iii) A point of contact for scientific information about the clinical trial results.

(iv) Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.
42 U.S.C. § 282(j)(3)(D)(ii)(I)(aa)

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(aa) each applicable drug clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title; and
42 U.S.C. § 282(j)(3)(D)(ii)(II)(aa)

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(aa) an applicable drug clinical trial for a drug that is not approved under section 355 of title 21 and not licensed under section 262 of this title (whether approval or licensure was sought or not); and
42 U.S.C. § 282(j)(3)(E)(iv)

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(iv) With respect to an applicable clinical trial that is completed before the drug is initially approved under section 355 of title 21 or initially licensed under section 262 of this title, or the device is initially cleared under section 360(k) or initially approved under section 360e or 360j(m) of title 21, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m), as applicable.
42 U.S.C. § 282(j)(3)(E)(v)(I)

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(I) With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 355 of title 21, licensing under section 262 of this title, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date—

(aa) the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);

(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or

(cc) except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.
42 U.S.C. § 282(j)(3)(E)(v)(I)(aa)

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(aa) the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);
42 U.S.C. § 282(j)(3)(E)(v)(I)(bb)

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(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or
42 U.S.C. § 282(j)(3)(E)(v)(I)(cc)

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(cc) except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.
42 U.S.C. § 282(j)(3)(E)(v)(II)

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(II) If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 262 of this title or section 355, 360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial.
42 U.S.C. § 282(j)(4)(A)

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(A) A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 262 of this title or under section 355, 360(k), 360e, or 360j(m) of title 21 in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial.
42 U.S.C. § 282(j)(4)(B)(ii)(I)

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(I) an applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or for a device that is cleared under section 360(k) of title 21 or approved under section 360e or section 360j(m) of title 21, whose completion date is on or after the date 10 years before September 27, 2007; or
42 U.S.C. § 282(j)(5)(B)

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(B) At the time of submission of an application under section 355 of title 21, section 360e of title 21, section 360j(m) of title 21, or section 262 of this title, or submission of a report under section 360(k) of title 21, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers.
42 U.S.C. § 284m–1(b)(2)(A)

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(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;
42 U.S.C. § 287a(a)(1)

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(1) The term “biological product” has the meaning given such term in section 262 of this title.
42 U.S.C. § 290dd–4(b)(4)(B)

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(B) establish policies and procedures, pursuant to Federal and State law, that address the provision of overdose reversal medication, the administration of all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and all biological products licensed under section 262 of this title to treat substance use disorder, and subsequent continuation of, or referral to, evidence-based treatment for patients with a substance use disorder who have experienced a non-fatal drug overdose, in order to support long-term treatment, prevent relapse, and reduce recidivism and future overdose; and
42 U.S.C. § 290dd–4(b)(5)(A)

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(A) all drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and all biological products licensed under section 262 of this title to treat substance use disorders or reverse overdose, pursuant to Federal and State law;
42 U.S.C. § 290ee–7(g)(1)(B)(i)

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(i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all biological products licensed under section 262 of this title to treat substance use disorders or reverse overdoses, pursuant to Federal and State law;
42 U.S.C. § 300aa–22(b)(2)

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(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—

(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23(d)(2) of this title, or

(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
42 U.S.C. § 300aa–23(d)(2)(A)

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(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title,
42 U.S.C. § 1320f–1(e)(1)(B)(i)

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(i) that is licensed under section 262(a) of this title and is marketed under section 262 of this title;
42 U.S.C. § 1320f–3(c)(4)(B)(i)

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(i) A vaccine that is licensed under section 262 of this title and marketed pursuant to such section.
42 U.S.C. § 1320f–3(c)(5)(B)

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(B) The term “long-monopoly drug” shall not include a vaccine that is licensed under section 262 of this title and marketed pursuant to such section.
42 U.S.C. § 1395w–102(b)(8)(B)

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(B) For purposes of this paragraph, the term “adult vaccine recommended by the Advisory Committee on Immunization Practices” means a covered part D drug that is a vaccine licensed under section 351 of the Public Health Service Act [42 U.S.C. 262] for use by adult populations and administered in accordance with recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
42 U.S.C. § 1395w–102(b)(9)(C)

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(C) In this paragraph, the term “covered insulin product” means an insulin product that is a covered part D drug covered under the prescription drug plan or MA–PD plan that is approved under section 355 of title 21 or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262] and marketed pursuant to such approval or licensure, including any covered insulin product that has been deemed to be licensed under section 351 of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such section.
42 U.S.C. § 1395w–102(e)(1)

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(1) Except as provided in this subsection, for purposes of this part, the term “covered part D drug” means—

(A) a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r–8(k)(2) of this title;

(B) a biological product described in clauses (i) through (iii) of subparagraph (B) of such section or insulin described in subparagraph (C) of such section and medical supplies associated with the injection of insulin (as defined in regulations of the Secretary); or

(C) for the period beginning on December 29, 2022, and ending on December 31, 2026, an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 360bbb–3 of title 21, on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed. Reg. 18250 et seq.),

and such term includes a vaccine licensed under section 262 of this title (and, for vaccines administered on or after January 1, 2008, its administration) and any use of a covered part D drug for a medically accepted indication (as defined in paragraph (4)).
42 U.S.C. § 1395w–114a(g)(2)(A)

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(A) approved under a new drug application under section 355(b) of title 21 or, in the case of a biologic product, licensed under section 262 of this title (other than, with respect to a plan year before 2019, a product licensed under subsection (k) of such section 262); and
42 U.S.C. § 1395w–114b(g)(1)(C)(iii)

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(iii) a biological licensed under section 262 of this title.
42 U.S.C. § 1395w–114c(g)(2)(A)(i)

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(i) approved under a new drug application under section 355(c) of title 21 or, in the case of a biologic product, licensed under section 262 of this title; and
42 U.S.C. § 1395w–3a(c)(6)(H)

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(H) The term “biosimilar biological product” means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 262 of this title.
42 U.S.C. § 1395w–3a(c)(6)(I)

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(I) The term “reference biological product” means the biological product licensed under such section 262 of this title that is referred to in the application described in subparagraph (H) of the biosimilar biological product.
42 U.S.C. § 1396d(ee)(1)(A)

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(A) means all drugs approved under section 355 of title 21, including methadone, and all biological products licensed under section 262 of this title to treat opioid use disorders; and
42 U.S.C. § 1396r–8(k)(2)(B)(ii)

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(ii) is licensed under section 262 of this title, and
42 U.S.C. § 18122(2)(C)

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(C) The term “medical malpractice or medical product liability action or claim” means a medical malpractice action or claim (as defined in section 11151(7) of this title) and includes a liability action or claim relating to a health care provider’s prescription or provision of a drug, device, or biological product (as such terms are defined in section 321 of title 21 or section 262 of this title).

Citations to §262(a)

21 U.S.C. § 355c(a)(3)(A)(ii)(II)(aa)

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(aa) for which an approved application under section 355(b) of this title or section 262(a) of title 42 to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and
21 U.S.C. § 355c–1(b)(12)(A)

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(A) the average length of time after the approval of an application under section 355(b)(1) of this title or section 262(a) of title 42 before studies conducted pursuant to such section 355a of this title, 355c of this title, or section 262(m) of title 42 are completed, submitted, and incorporated into labeling;
21 U.S.C. § 355c–1(b)(12)(D)

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(D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 355(b)(1) of this title or section 262(a) of title 42; and
21 U.S.C. § 355f(c)(4)

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(4) an application pursuant to section 262(a) of title 42.
21 U.S.C. § 355f(d)(1)

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(1) The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time before the submission of an application under section 355(b) of this title or section 262(a) of title 42 for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product.
21 U.S.C. § 355g(f)(2)(A)(ii)

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(ii) section 262(a) of title 42; or
21 U.S.C. § 356(c)(1)(A)

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(A) The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 355(c) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as “accelerated approval”.
21 U.S.C. § 356(e)(2)

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(2) Nothing in this section shall be construed to alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard in section 355(d) of this title) or under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]. Such sections and standards of evidence apply to the review and approval of products under this section, including whether a product is safe and effective. Nothing in this section alters the ability of the Secretary to rely on evidence that does not come from adequate and well-controlled investigations for the purpose of determining whether an endpoint is reasonably likely to predict clinical benefit as described in subsection (b)(1)(B).
21 U.S.C. § 356(g)(6)

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(6) An application for a regenerative advanced therapy under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] may be—

(A) eligible for priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012; and

(B) eligible for accelerated approval under subsection (c), as agreed upon pursuant to subsection (a)(3)(B), through, as appropriate—

(i) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or

(ii) reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.
21 U.S.C. § 356(h)(7)

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(7) If, after approval of a drug under this subsection, the Secretary approves a broader indication for such drug under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], the Secretary may remove any postmarketing conditions, including requirements with respect to labeling and review of promotional materials under paragraph (3), applicable to the approval of the drug under this subsection.
21 U.S.C. § 356k(d)(2)

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(2) If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate.
21 U.S.C. § 356k(e)(1)

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(1) engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 355(b) of this title or safety, purity, or potency under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];
21 U.S.C. § 356k(f)

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(f) The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b) of this title or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 360bbb–3 of this title, in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that—

(1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or

(2) the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1).
21 U.S.C. § 356k(g)

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(g) A sponsor of more than one application approved under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for drugs that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable drug or biological product.
21 U.S.C. § 356k(i)(2)

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(2) confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing information contained in another application submitted by the holder of an approved application under section 355(c) of this title or of a license under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].
21 U.S.C. § 360bbb–0a(a)(2)(C)(i)

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(i) for which an application has been filed under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or
21 U.S.C. § 360bbb–0a(b)

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(b) Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 352(f), 353(b)(4), 355(a), and 355(i) of this title, section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], and parts 50, 56, and 312 of title 21, Code of Federal Regulations (or any successor regulations), provided that the sponsor of such eligible investigational drug or any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section is in compliance with the applicable requirements set forth in sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs.
21 U.S.C. § 360bbb–3(h)(1)

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(1) The Secretary shall promptly publish on the internet website of the Food and Drug Administration and in the Federal Register a notice of each authorization, and each termination or revocation of an authorization under this section, and an explanation of the reasons therefor (which may include a summary of data or information that has been submitted to the Secretary in an application, request, or submission under this section or section 355(b), 355(i), 355(j), 360b(b), 360b(j), 360b(n), 360e, 360(k), 360c(f)(2), 360j(g), 360j(m), 360ccc, or 360ccc–1 of this title, or section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), (k)], even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission). The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration, which may include a summary of the data and information supporting such revisions.
21 U.S.C. § 360bbb–4a(a)(3)

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(3) The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the material threat medical countermeasure application.
21 U.S.C. § 360bbb–4a(b)(2)

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(2) The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
21 U.S.C. § 360bbb–4a(c)(4)(A)

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(A) The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the priority review voucher is used.
21 U.S.C. § 360bbb–4a(d)(2)

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(2) The Secretary approves a drug pursuant to an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the sponsor of the application used a priority review voucher issued under this section.
21 U.S.C. § 360bbb–4b(e)(2)

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(2) alter the standards of evidence with respect to approval, licensure, or clearance, as applicable, of drugs, biological products, or devices under this Act [this chapter] or section 351 of the Public Health Service Act [42 U.S.C. 262], including, as applicable, the substantial evidence standards under sections 355(d) and 360b(d) of this title and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or
21 U.S.C. § 360bbb–4b(f)(2)

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(2) The term “medical countermeasure submission” means an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new animal drug under section 360ccc of this title, an investigational device application under section 360j(g) of this title, an application with respect to a device under section 360e(c) of this title, a request for classification of a device under section 360c(f)(2) of this title, a notification with respect to a device under section 360(k) of this title, or a request for an emergency use authorization under section 360bbb–3 of this title to support—

(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or

(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.
21 U.S.C. § 360bbb–8c(b)(1)

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(1) Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application.
21 U.S.C. § 360ff(a)(2)

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(2) The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the rare pediatric disease product application.
21 U.S.C. § 360ff(a)(4)(B)(ii)(I)

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(I) that contains no active ingredient that has been previously approved in any other application under section 351(a) or 351(k) of the Public Health Service Act [42 U.S.C. 262(a), 262(k)]; and
21 U.S.C. § 360ff(a)(4)(B)(ii)(II)

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(II) that is the subject of an application submitted under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)];
21 U.S.C. § 360ff(c)(4)(A)

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(A) The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.
21 U.S.C. § 360ff(f)(1)(B)

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(B) The Secretary approves a drug pursuant to an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the sponsor of the application used a priority review voucher under this section.
21 U.S.C. § 360ff(f)(2)

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(2) If, after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, a sponsor of an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug uses a priority review voucher under this section for such application, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a document—

(A) notifying such Committees of the use of such voucher; and

(B) identifying the drug for which such priority review voucher is used.
21 U.S.C. § 360ff–1(b)

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(b) The Secretary may, consistent with applicable standards for approval under this chapter or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information—

(1) previously developed by the same sponsor (or another sponsor that has provided the sponsor with a contractual right of reference to such data and information); and

(2) submitted by a sponsor described in paragraph (1) in support of one or more previously approved applications that were submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act,

for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject of an application or applications described in paragraph (2) or for a variant protein targeted drug that is the same or incorporates or utilizes the same variant protein targeted drug, as the drug or drugs that are the subject of an application or applications described in paragraph (2).
21 U.S.C. § 360ff–1(c)(1)(A)

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(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening;
21 U.S.C. § 360ff–1(c)(3)(A)

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(A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title) that is serious or life-threatening;
21 U.S.C. § 360ff–1(d)(2)

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(2) confer any new rights, beyond those authorized under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] prior to December 13, 2016, with respect to the permissibility of a sponsor referencing information contained in another application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)].
21 U.S.C. § 360n–1(a)

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(a) If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.
21 U.S.C. § 381(d)(4)

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(4) The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to paragraph (3) unless the importation complies with section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of tissue is not permitted pursuant to paragraph (3) unless the importation complies with section 361 of the Public Health Service Act [42 U.S.C. 264].
21 U.S.C. § 381(u)(1)(B)(i)(II)(aa)

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(aa) an investigational use exemption has been authorized under section 355(i) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; and
21 U.S.C. § 397(a)(1)

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(1) The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.
21 U.S.C. § 811(j)(2)(B)

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(B) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c), 360b, 360ccc] or section 262(a) of title 42, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc–1], with respect to the drug described in paragraph (1).
42 U.S.C. § 1320f–1(e)(1)(B)(i)

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(i) that is licensed under section 262(a) of this title and is marketed under section 262 of this title;
42 U.S.C. § 1320f–1(e)(2)(B)(ii)(I)

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(I) has been licensed under section 262(a) of this title;¹ and
42 U.S.C. § 1320f–3(c)(4)(A)

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(A) In this part, subject to subparagraph (B), the term “extended-monopoly drug” means, with respect to an initial price applicability year, a selected drug for which at least 12 years, but fewer than 16 years, have elapsed since the date of approval of such drug under section 355(c) of title 21 or since the date of licensure of such drug under section 262(a) of this title, as applicable.
42 U.S.C. § 1320f–3(c)(5)(A)

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(A) In this part, subject to subparagraph (B), the term “long-monopoly drug” means, with respect to an initial price applicability year, a selected drug for which at least 16 years have elapsed since the date of approval of such drug under section 355(c) of title 21 or since the date of licensure of such drug under section 262(a) of this title, as applicable.
42 U.S.C. § 1320f–3(e)(1)(D)

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(D) Data on pending and approved patent applications, exclusivities recognized by the Food and Drug Administration, and applications and approvals under section 355(c) of title 21 or section 262(a) of this title for the drug.
42 U.S.C. § 17951(b)

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(b) The standards governing the privacy and security of individually identifiable health information promulgated by the Secretary under sections 262(a) and 264 of the Health Insurance Portability and Accountability Act of 1996 shall remain in effect to the extent that they are consistent with this subchapter. The Secretary shall by rule amend such Federal regulations as required to make such regulations consistent with this subchapter.

Citations to §262(a)(2)(E)

21 U.S.C. § 355(c)(5)(C)(i)

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(i) the number of applications reviewed solely under subparagraph (A) or section 262(a)(2)(E) of title 42;
21 U.S.C. § 355(c)(5)(C)(ii)

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(ii) the average time for completion of review under subparagraph (A) or section 262(a)(2)(E) of title 42;
21 U.S.C. § 355(c)(5)(C)(iii)

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(iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under subparagraph (A) or section 262(a)(2)(E) of title 42; and
21 U.S.C. § 355(c)(5)(C)(iv)

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(iv) the number of applications reviewed under subparagraph (A) or section 262(a)(2)(E) of title 42 for which the Secretary made use of full data sets in addition to the qualified data summary.

Citations to §262(a)(3)

21 U.S.C. § 356(a)(2)

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(2) The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].
21 U.S.C. § 356(b)(2)

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(2) The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].
21 U.S.C. § 356(g)(3)

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(3) The sponsor of a drug may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, submission of an application for the investigation of the drug under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].
21 U.S.C. § 356k(c)

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(c) A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)] for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request.
21 U.S.C. § 356–1(a)(2)

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(2) an application for the investigation of the drug under section 355(i) of this title or section 262(a)(3) of title 42.
21 U.S.C. § 357(b)(2)(B)

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(B) supporting the investigational use of a drug or biological product under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].
21 U.S.C. § 360bbb–0a(a)(2)(C)(ii)(II)

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(II) is the subject of an active investigational new drug application under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)], as applicable; and
42 U.S.C. § 1396d(gg)(2)(A)(ii)

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(ii) The clinical trial is conducted pursuant to an investigational new drug exemption under section 355(i) of title 21 or an exemption for a biological product undergoing investigation under section 262(a)(3) of this title.

Citations to §262(h)

21 U.S.C. § 331(w)

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(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title; the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 381(e) or 382 of this title, or with section 262(h) of title 42; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.
21 U.S.C. § 381(d)(3)(A)(i)(I)

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(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].
21 U.S.C. § 381(d)(3)(B)

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(B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

Citations to §262(i)

21 U.S.C. § 353(iii)(9)(B)

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(B) The term “biological product” has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).
21 U.S.C. § 360bbb–8a(b)

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(b) In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].
21 U.S.C. § 399h(h)(2)

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(2) The term “biological product” has the meaning given such term in section 262(i) of title 42.
42 U.S.C. § 247d–6a(a)(2)(A)

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(A) The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—

(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;

(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or

(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
42 U.S.C. § 247d–6b(c)(1)(B)

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(B) For purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that—

(I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;

(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and

(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or

(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or

(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].
42 U.S.C. § 247d–6d(i)(1)(C)

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(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b]; or
42 U.S.C. § 247d–6d(i)(7)

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(7) The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),² biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h))² that is—

(i) a product manufactured, used, designed, developed, modified, licensed, or procured—

(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or

(II) to limit the harm such pandemic or epidemic might otherwise cause;

(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or

(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and

(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;

(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or

(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
42 U.S.C. § 263–1(a)(2)(D)

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(D) an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section 262(k) of this title and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product.
42 U.S.C. § 287a(a)(3)

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(3) The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,¹ biological product (as that term is defined by section 262(i)² of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center—

(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and

(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.
42 U.S.C. § 1320f(c)(4)

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(4) The term “reference product” has the meaning given such term in section 262(i) of this title.
42 U.S.C. § 1395w–112(h)(1)(C)(i)(IV)

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(IV) Where a reference product (as defined in section 262(i) of this title) is covered by the plan, the following information:

(aa) A list of currently marketed biosimilar biological products licensed under section 262(k) of this title pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to.

(bb) The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product.

(cc) Where a biosimilar biological product listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the reference product, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the biosimilar biological products described in item (aa), had the plan provided coverage for such products on the same formulary tier as the reference product.

(dd) A written justification for providing more favorable coverage of the reference product than the biosimilar biological products described in item (aa).

(ee) The number of currently marketed biosimilar biological products licensed under section 262(k) of this title, pursuant to an application that refers to such reference product.

Citations to §262(k)

21 U.S.C. § 355(b)(5)(B)(ii)

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(ii) with respect to an application for approval of a biological product under section 262(k) of title 42, of any necessary clinical study or studies.
21 U.S.C. § 355(q)(1)(A)

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(A) The Secretary shall not delay approval of a pending application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42 because of any request to take any form of action relating to the application, either before or during consideration of the request, unless—

(i) the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30 or 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and

(ii) the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.

Consideration of the petition shall be separate and apart from review and approval of any application.
21 U.S.C. § 355(q)(4)(B)

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(B) Paragraph (2) does not apply to a petition addressing issues concerning an application submitted pursuant to section 262(k) of title 42.
21 U.S.C. § 355(q)(5)(A)

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(A) For purposes of this subsection, the term “application” means an application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42.
21 U.S.C. § 355c(a)(3)(A)(ii)(I)(aa)

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(aa) for which an approved application under section 355(j) under² this title or under section 262(k) of title 42 is in effect; and
21 U.S.C. § 355–2(a)(4)

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(4) the term “eligible product developer” means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 355 of this title or for licensing pursuant to an application under section 262(k) of title 42;
21 U.S.C. § 355–2(a)(10)(A)(ii)

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(ii) section 262(k) of title 42; and
21 U.S.C. § 360bbb–4b(f)(2)

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(2) The term “medical countermeasure submission” means an investigational new drug application under section 355(i) of this title, a new drug application under section 355(b) of this title, or an abbreviated new drug application under section 355(j) of this title, a biological product license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [42 U.S.C. 262(k)], a new animal drug application under section 360b(b)(1) of this title or abbreviated new animal drug application under section 360b(b)(2) of this title, an application for conditional approval of a new animal drug under section 360ccc of this title, an investigational device application under section 360j(g) of this title, an application with respect to a device under section 360e(c) of this title, a request for classification of a device under section 360c(f)(2) of this title, a notification with respect to a device under section 360(k) of this title, or a request for an emergency use authorization under section 360bbb–3 of this title to support—

(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or

(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.
21 U.S.C. § 379d–4(b)(1)(A)

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(A) the number of applications for approval filed under section 262(k) of title 42; and
21 U.S.C. § 379d–4(b)(2)

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(2) As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under subpart 2¹ are not used to review an application under section 262(k) of title 42.
21 U.S.C. § 379j–51(4)(A)

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(A) Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under section 262(k) of title 42.
21 U.S.C. § 379j–51(4)(B)(ii)

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(ii) an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;
21 U.S.C. § 379j–51(4)(B)(iii)

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(iii) an application filed under section 262(k) of title 42 with respect to—

(I) whole blood or a blood component for transfusion;

(II) an in vitro diagnostic biological product; or

(III) a biological product for further manufacturing use only; or
21 U.S.C. § 379j–51(4)(B)(iv)

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(iv) an application for licensure under section 262(k) of title 42 that is submitted by a State or Federal Government entity for a product that is not distributed commercially.
21 U.S.C. § 379j–51(8)(A)(i)

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(i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and
21 U.S.C. § 379j–51(13)(D)

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(D) Activities necessary for the release of lots of biosimilar biological products under section 262(k) of title 42.
42 U.S.C. § 263–1(a)(2)(D)

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(D) an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section 262(k) of this title and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product.
42 U.S.C. § 284m(c)(1)(A)(i)

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(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] or section 262(k) of this title; or
42 U.S.C. § 1320f–1(c)(1)(A)(ii)

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(ii) under section 262(k) of this title using such drug as the reference product; and
42 U.S.C. § 1320f–1(e)(1)(B)(iii)

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(iii) that is not the reference product for any biological product that is licensed and marketed under section 262(k) of this title.
42 U.S.C. § 1320f–1(f)(1)(A)

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(A) Subject to subparagraph (B), in the case of a biological product that would (but for this subsection) be an extended-monopoly drug (as defined in section 1320f–3(c)(4) of this title) included as a selected drug on the list published under subsection (a) with respect to an initial price applicability year, the rules described in paragraph (2) shall apply if the Secretary determines that there is a high likelihood (as described in paragraph (3)) that a biosimilar biological product (for which such biological product will be the reference product) will be licensed and marketed under section 262(k) of this title before the date that is 2 years after the selected drug publication date with respect to such initial price applicability year.
42 U.S.C. § 1320f–1(f)(1)(B)(ii)(III)(aa)

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(aa) The manufacturing schedule for such biosimilar biological product submitted to the Food and Drug Administration during its review of the application under such section 262(k) of this title.
42 U.S.C. § 1320f–1(f)(2)(B)(i)

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(i) If, during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection (a) but for subparagraph (A) and the selected drug publication date with respect to the initial price applicability year that is 1 year after the initial price applicability year for which such biological product would have been included as a selected drug on such list, the Secretary determines that the biosimilar biological product for which the manufacturer submitted the request under paragraph (1)(B)(i)(II) (and for which the Secretary previously made a high likelihood determination under paragraph (3)) has not been licensed and marketed under section 262(k) of this title, the Secretary shall, at the request of such manufacturer—

(I) reevaluate whether there is a high likelihood (as described in paragraph (3)) that such biosimilar biological product will be licensed and marketed under such section 262(k) before the date that is 2 years after the selected drug publication date for which such biological product would have been included as a selected drug on such list published but for subparagraph (A); and

(II) evaluate whether, on the basis of clear and convincing evidence, the manufacturer of such biosimilar biological product has made a significant amount of progress (as determined by the Secretary) towards both such licensure and the marketing of such biosimilar biological product (based on information from items described in subclauses (I)(bb) and (II) of paragraph (1)(B)(ii)) since the receipt by the Secretary of the request made by such manufacturer under paragraph (1)(B)(i)(I).
42 U.S.C. § 1320f–1(f)(2)(B)(i)(I)

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(I) reevaluate whether there is a high likelihood (as described in paragraph (3)) that such biosimilar biological product will be licensed and marketed under such section 262(k) before the date that is 2 years after the selected drug publication date for which such biological product would have been included as a selected drug on such list published but for subparagraph (A); and
42 U.S.C. § 1320f–1(f)(2)(D)(iii)

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(iii) In no case shall the Secretary delay the inclusion of a biological product on the list published under subsection (a) if more than 1 year has elapsed since the biosimilar biological product has been licensed under section 262(k) of this title and marketing has not commenced for such biosimilar biological product.
42 U.S.C. § 1320f–1(f)(3)(A)

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(A) an application for licensure under section 262(k) of this title for the biosimilar biological product has been accepted for review or approved by the Food and Drug Administration; and
42 U.S.C. § 1395w–112(h)(1)(C)(i)(IV)(aa)

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(aa) A list of currently marketed biosimilar biological products licensed under section 262(k) of this title pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to.
42 U.S.C. § 1395w–112(h)(1)(C)(i)(IV)(ee)

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(ee) The number of currently marketed biosimilar biological products licensed under section 262(k) of this title, pursuant to an application that refers to such reference product.
42 U.S.C. § 1395w–114a(g)(2)(A)

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(A) approved under a new drug application under section 355(b) of title 21 or, in the case of a biologic product, licensed under section 262 of this title (other than, with respect to a plan year before 2019, a product licensed under subsection (k) of such section 262); and
42 U.S.C. § 1395w–114b(b)(1)(C)(ii)

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(ii) in the case of a generic part D rebatable drug (described in subsection (g)(1)(C)(ii)) or a biosimilar (defined as a biological product licensed under section 262(k) of this title), when the Secretary determines there is a severe supply chain disruption during the applicable period, such as that caused by a natural disaster or other unique or unexpected event; and

Citations to §262(k)(4)

21 U.S.C. § 355c(l)(1)

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(1) A biological product that is biosimilar to a reference product under section 262 of title 42, and that the Secretary has not determined to meet the standards described in subsection (k)(4) of such section for interchangeability with the reference product, shall be considered to have a new active ingredient under this section.
21 U.S.C. § 379j–51(14)

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(14) The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42.

Citations to §262(k)(7)

42 U.S.C. § 284m(c)(1)(B)

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(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and

Citations to §262(k)(9)(A)

21 U.S.C. § 356i(c)

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(c) Within 180 days of December 29, 2022, all holders of applications approved under subsection (a) or (k) of section 262 of title 42 shall review the information in the list published under section 262(k)(9)(A) of title 42 and shall submit a written notice to the Secretary—

(1) stating that all of the application holder’s biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or

(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale.
21 U.S.C. § 356i(c)(1)

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(1) stating that all of the application holder’s biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or
21 U.S.C. § 356i(c)(2)

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(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale.
21 U.S.C. § 356i(d)(2)

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(2) identify the application holder’s biological products as discontinued in the list published under section 262(k)(9)(A) of title 42, except that the Secretary shall remove from the list in accordance with section 262(k)(9)(B) of such title biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.
21 U.S.C. § 356i(e)

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(e) The Secretary shall update the list published under section 355(j)(7)(A) of this title based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with section 355(j)(7)(C) of this title. The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42. The Secretary shall make monthly updates to the lists referred to in the preceding sentences based on the information provided pursuant to subsections (a) and (b), and shall update such lists based on the information provided under subsection (c) as soon as practicable.

Citations to §262(k)(9)(B)

21 U.S.C. § 356i(d)(2)

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(2) identify the application holder’s biological products as discontinued in the list published under section 262(k)(9)(A) of title 42, except that the Secretary shall remove from the list in accordance with section 262(k)(9)(B) of such title biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.
21 U.S.C. § 356i(e)

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(e) The Secretary shall update the list published under section 355(j)(7)(A) of this title based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with section 355(j)(7)(C) of this title. The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42. The Secretary shall make monthly updates to the lists referred to in the preceding sentences based on the information provided pursuant to subsections (a) and (b), and shall update such lists based on the information provided under subsection (c) as soon as practicable.

Citations to §262(m)

21 U.S.C. § 355c–1(b)(12)

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(12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act,¹ regarding earlier submission of pediatric studies under sections 355a and 355c of this title and section 262(m) of title 42, including—

(A) the average length of time after the approval of an application under section 355(b)(1) of this title or section 262(a) of title 42 before studies conducted pursuant to such section 355a of this title, 355c of this title, or section 262(m) of title 42 are completed, submitted, and incorporated into labeling;

(B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;

(C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;

(D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 355(b)(1) of this title or section 262(a) of title 42; and

(E) the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;
21 U.S.C. § 355c–1(b)(12)(A)

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(A) the average length of time after the approval of an application under section 355(b)(1) of this title or section 262(a) of title 42 before studies conducted pursuant to such section 355a of this title, 355c of this title, or section 262(m) of title 42 are completed, submitted, and incorporated into labeling;
21 U.S.C. § 355c–1(b)(13)

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(13) a list of sponsors of applications or holders of approved applications who received exclusivity under such section 355a of this title or such section 262(m) of title 42 after receiving a letter issued under such section 355c(d)(1) of this title for any drug or biological product before the studies referred to in such letter were completed and submitted;
42 U.S.C. § 284m(c)(1)

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(1) The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], or section 262(m) of this title, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—

(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] or section 262(k) of this title; or

(ii) there is a submitted application that could be approved under the criteria of such section; and

(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and

(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.
42 U.S.C. § 284m(c)(2)

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(2) The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or section 262(m) of this title, including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.