§360n–1 — Title 21 Food and Drugs | U.S. Code

Summary

If the Secretary names a drug a qualified infectious disease product, the Secretary must give priority review to the first approval application filed for that drug that needs clinical data (except bioavailability studies) to show it is safe and works. The Secretary may also give priority review to other human drug applications or to efficacy supplements if they otherwise meet the normal priority-review rules.

Title 21, §360n–1

Food and Drugs — Source: USLM XML via OLRC

(a)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)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.

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].”

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