21 U.S.C. § 360n-1 Priority Review For Qualified Infectious Disease Products

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 360n-1

(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.

Cite as 21 U.S.C. § 360n-1

Source: 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.