Sec. 5. Priority review; fast track product
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/bill/116/hr/2858/ih/section-5·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 524A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n–1(a) ) is amended by striking then the Secretary shall give priority review to the first application submitted for approval for such drug under section 505(b) and inserting or if the drug is a biological product intended to treat blastomycosis, coccidioidomycosis, histoplasmosis, or sporotrichosis, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 505(b) of this Act or section 351(a) of the Public Health Service Act . The amendment made by paragraph
(1)applies to an application submitted under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) only if such application is submitted on or after the date of enactment of this Act. Section 506(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(b)(1) ) is amended by striking or if the Secretary designates the drug as a qualified infectious disease product under section 505E(d) and inserting if the Secretary designates the drug as a qualified infectious disease product under section 505E(d), or if the drug is a biological product intended to treat blastomycosis, coccidioidomycosis, histoplasmosis, or sporotrichosis .
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- 21 USC 360n–1(a)
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