21 U.S.C. § 360n–1
Priority review for qualified infectious disease products
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 360n–1, Priority review for qualified infectious disease products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454288
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Full text
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.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Food and Drug Administration Safety and Innovation ActHouse: no recorded tallySenate: 96–1
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally
- Consolidated Appropriations Act, 2023House: 225–201Senate: no recorded tally