21 U.S.C. § 356–1: Accelerated approval of…

Summary

The Secretary of Health and Human Services can label a priority countermeasure as a fast-track drug under section 356 or as a device with priority review under section 360e(d)(5). That label can be given before the sponsor asks for it or before an investigational application is filed under section 355(i) or 42 U.S.C. 262(a)(3). A sponsor may decline the label. A drug seeking approval under section 355(b) or 42 U.S.C. 262 based on animal-study evidence under section 123 1 can also get fast-track status. A priority countermeasure that is a drug or biological product will be treated as a priority product for FDA performance goals. "Priority countermeasure" is defined in 42 U.S.C. 247d–6(h)(4). "Priority drugs or biological products" refers to the products named in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

Title 21, §356–1

Food and Drugs, Source: USLM XML via OLRC

(a)In general

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) of this title. Such a designation may be made prior to the submission of— (1)

(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.

(b)Use of animal trials

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 123 1 may be designated as a fast track product for purposes of this section.

(c)Priority review of drugs and biological products

A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.

(d)Definitions

For purposes of this title: 1

(1)The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4) 1 of title 42.

(2)The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 360e(d)(5) of this title, referred to in subsec. (a), was struck out and former subsec. (d)(6) redesignated subsec. (d)(5) of section 360e by Pub. L. 114–255, div. A, title III, § 3051(c)(1), Dec. 13, 2016, 130 Stat. 1124. section 360e(d)(5) no longer relates to grants of review priority. section 123, referred to in subsec. (b), is section 123 of Pub. L. 107–188, title I,

June 12, 2002, 116 Stat. 613, which is not classified to the Code. This title, referred to in subsec. (d), is title I of Pub. L. 107–188,

June 12, 2002, 116 Stat. 596, which enacted this section, section 669a of Title 29, Labor, and section 244, 245, 247d–3a, 247d–3b, 247d–7a to 247d–7d, 300hh, 300hh–11 to 300hh–13, 1320b–5, and 7257d of Title 42, The Public Health and Welfare, amended sections 247d to 247d–6, 264, 266, 290hh–1, and 5196b of Title 42, and enacted provisions set out as notes preceding section 8101 of Title 38, Veterans’ Benefits, and under section 201, 244, 247d, 247d–6, 300hh, 300hh–12, and 1320b–5 of Title 42. For complete classification of this title to the Code, see Tables. section 247d–6(h)(4) of title 42, referred to in subsec. (d)(1), was redesignated section 247d–6(e)(4) by Pub. L. 109–417, title III, § 304(3), Dec. 19, 2006, 120 Stat. 2861. section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title. Codification Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§356–1 Accelerated Approval of Priority Countermeasures

Summary

Title 21, §356–1

Notes & Related Subsidiaries

Editorial Notes

References in Text

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