FEDERAL · 21 U.S.C. · Chapter 9
Priority review for qualified infectious disease products
21 U.S.C. § 360n–1
Title21 — Food and Drugs
Chapter9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
SubchapterV
PartA
Current throughPub. L. 119-99
This text of 21 U.S.C. § 360n–1 (Priority review for qualified infectious disease products) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Bluebook
21 U.S.C. § 360n–1.
Text
(a)In general
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.
(b)Construction
Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review.
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History
(June 25, 1938, ch. 675, §524A, as added Pub. L. 112–144, title VIII, §802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, §3212(b), Dec. 29, 2022, 136 Stat. 5826.)
Editorial Notes
Editorial Notes
Amendments
2022—Subsec. (a). Pub. L. 117–328 inserted ", or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness" before period at end.
2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted "the first application" for "any application", and added subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date
Pub. L. 112–144, title VIII, §802(b), July 9, 2012, 126 Stat. 1079, provided that: "Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act [July 9, 2012]."
Amendments
2022—Subsec. (a). Pub. L. 117–328 inserted ", or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness" before period at end.
2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted "the first application" for "any application", and added subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date
Pub. L. 112–144, title VIII, §802(b), July 9, 2012, 126 Stat. 1079, provided that: "Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act [July 9, 2012]."
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Bluebook (online)
21 U.S.C. § 360n–1, Counsel Stack Legal Research, https://law.counselstack.com/usc/21/360n–1.