Priority review for qualified infectious disease products

21 U.S. Code § 360n-1. Priority review for qualified infectious disease products

(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.
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