§ 360n–1. Priority review for qualified infectious disease products
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/usc/title-21/section-360n-1A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. 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 .)
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- Pub. L. 112-144
- 126 Stat. 1079
- 130 Stat. 1154
- 136 Stat. 5826
- 21 USC 360n–1
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§ 360n–1
Priority review for qualified infectious disease products
Stat. Comp.×3
Fed. Reg.×1
Pub. L.Pub. L. 112-144
Stat.126 Stat. 1079
Stat.130 Stat. 1154
Stat.136 Stat. 5826
Cite21 USC 360n–1
Cites 8Cited by 4 across 2 sources