Fabio
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Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
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| LegalText | 21 U.S.C. § 360n–1 | Priority review for qualified infectious disease products | us | united_states_code | code_section | 21 | FOOD AND DRUGS | 9 | FEDERAL FOOD, DRUG, AND COSMETIC ACT | 360n–1 | 21 U.S.C. § 360n–1 | current | 119-100 | 2026-06-26 | official | https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip | /us/usc/t21/s360n–1 | data/legal/raw/us/code/title-21/usc21.xml | 93c44f1a3ee829e4c0d0bb0149759f43dedee8a94cb0b6b42be345c544015a56 | 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 | 06ba848d21599781aea0647e971adfc2d9a614a88178c512509d23f3aa4fd1a2 | 2026-07-04 | official |
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21 U.S.C. § 360n–1 - Priority review for qualified infectious disease products
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.
(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.)
Notes
Editorial Notes
Amendments2022—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 DatePub. 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].”