Title 21, Food and DrugsRelease 119-110
§360n–1 Priority Review for Qualified Infectious Disease Products
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part A — Drugs and Devices › § 360n–1
Summary
When the Secretary calls a drug a qualified infectious disease product, the first application for it that needs clinical data (not just bioavailability studies) must get priority review. This does not stop the Secretary from giving priority review to other applications or efficacy supplements.
Full Legal Text
Title 21, §360n–1
Food and Drugs, Source: USLM XML via OLRC
(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.
Legislative History
Notes & Related Subsidiaries
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].”
Reference
Citations & Metadata
Citation
21 U.S.C. § 360n–1
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110