§360bbb. Expanded access to unapproved therapies and diagnostics — Inbound Citations
21 U.S.C. § 360bbb
Cited by 9 provisions in release 119-102.
Citations to 21 U.S.C. § 360bbb as a whole
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(5) Animal tests.
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(6) The mechanisms under section 360bbb of this title to provide for expanded access for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that is subject to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a physician may provide the drug under the mechanisms of section 360bbb of this title.
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(2) the term “eligible investigational drug” means an investigational drug (as such term is used in section 360bbb of this title)—(A) for which a Phase 1 clinical trial has been completed;(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];(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(ii) that is under investigation in a clinical trial that—(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(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(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 355(i) of this title; and
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(D) No diversity action plan shall be required for a submission described in section 360bbb of this title.
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(3) This subsection shall not apply to submissions described in section 360bbb of this title.
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(1) The Partnership may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of basic research and research associated with phase 3 clinical trials conducted with respect to investigational drugs that are the subjects of expanded access requests under section 360bbb of title 21.
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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;
Citations to §360bbb(b)
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(a) The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.
Citations to §360bbb(c)
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(i) under a treatment investigational new drug application that has been submitted to the Secretary under section 360bbb(c) of title 21; or