Federal · Title 21 — Food and Drugs
21 U.S.C. § 360n: Priority review for qualified infectious disease products
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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.
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