---
kind: "section"
citation: "21 U.S.C. § 360n–1"
title: "21"
title_heading: "Food and Drugs"
number: "360n–1"
heading: "Priority review for qualified infectious disease products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360n-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360n–1. Priority review for qualified infectious disease products

- (a) **In general—** If the [Secretary](/usc/21/321.md?p=d) designates a [drug](/usc/21/321.md?p=g-1) under [section 355f(d) of this title](/usc/21/355f.md?p=d) as a qualified infectious disease [product](/usc/21/360eee.md?p=13), then the [Secretary](/usc/21/321.md?p=d) shall give priority review to the first application submitted for approval for such [drug](/usc/21/321.md?p=g-1) under [section 355(b) of this title](/usc/21/355.md?p=b), or [section 262(a) of title 42](/usc/42/262.md?p=a), that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.
- (b) **Construction—** Nothing in this section shall prohibit the [Secretary](/usc/21/321.md?p=d) from giving priority review to a human [drug](/usc/21/321.md?p=g-1) application or efficacy supplement submitted for approval under [section 355(b) of this title](/usc/21/355.md?p=b) that otherwise meets the criteria for the [Secretary](/usc/21/321.md?p=d) to grant priority review.

## Source credit

(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

### 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].”