§356. Expedited approval of drugs for serious or life-threatening diseases or conditions — Inbound Citations
21 U.S.C. § 356
Cited by 19 provisions in release 119-102.
Citations to 21 U.S.C. § 356 as a whole
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(2) The failure to conduct a postmarket study under section 356 of this title, subpart H of part 314, or subpart E of part 601 of title 21, Code of Federal Regulations (or any successor regulations), is deemed to be a violation of paragraph (1).
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(a) The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e(d)(5)1 of this title. Such a designation may be made prior to the submission of—(1) a request for designation by the sponsor or applicant; or(2) an application for the investigation of the drug under section 355(i) of this title or section 262(a)(3) of title 42.Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.
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(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 356 of this title.
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(2) The request for a designation under paragraph (1) shall be made at the same time a request for designation of orphan disease status under section 360bb of this title or fast-track designation under section 356 of this title is made. Requesting designation under this subsection is not a prerequisite to receiving a priority review voucher under this section.
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(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;
Citations to §356(c)
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(ggg) The failure of a sponsor of a product approved under accelerated approval pursuant to section 356(c) of this title—(1) to conduct with due diligence any postapproval study required under section 356(c) of this title with respect to such product; or(2) to submit timely reports with respect to such product in accordance with section 356b(a)(2) of this title.
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(1) to conduct with due diligence any postapproval study required under section 356(c) of this title with respect to such product; or
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(2) Notwithstanding paragraph (1), a sponsor of a drug approved pursuant to accelerated approval shall submit to the Secretary a report of the progress of any study required under section 356(c) of this title, including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. The Secretary shall promptly publish on the website of the Food and Drug Administration, in an easily searchable format, the information reported under this paragraph.
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(1) Not later than 1 year after December 29, 2022, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the “Council”) within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 356(c) of this title.
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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
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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].
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(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title.
Citations to §356(c)(2)(A)
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(e) With respect to studies of the type required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under section 356(c)(2)(A) of this title or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.
Citations to §356(g)
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(c) For purposes of this section, the terms “regenerative medicine therapy” and “regenerative advanced therapy” have the meanings given such terms in section 356(g) of this title.
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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.
Citations to §356(h)
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(1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 356(h) of title 21;
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(B) drugs approved under section 356(h) of title 21.
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(1) For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 356(h) of title 21, the Secretary shall—(A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and(B) evaluate—(i) antimicrobial resistance data using a standardized approach; and(ii) trends in the utilization of drugs approved under such section 356(h) of title 21 with respect to patient populations.
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(ii) trends in the utilization of drugs approved under such section 356(h) of title 21 with respect to patient populations.