Sec. 501. Advancing qualified infectious disease product innovation
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Section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ) is amended— in subsection (c)— in paragraph (2), by striking ; or and inserting ; ; in paragraph (3), by striking the period and inserting ; or ; and by adding at the end the following: an application pursuant to section 351(a) of the Public Health Service Act. ; in subsection (d)(1), by inserting of this Act or section 351(a) of the Public Health Service Act after section 505(b) ; and by amending subsection
(g)to read as follows: The term qualified infectious disease product means a drug, including an antibacterial or antifungal drug or a biological product, for human use that— acts directly on bacteria or fungi or on substances produced by such bacteria or fungi; and is intended to treat a serious or life-threatening infection, including such an infection caused by— an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or qualifying pathogens listed by the Secretary under subsection (f). . Section 524A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n–1(a) ) is amended by inserting of this Act, or section 351(a) of the Public Health Service Act, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness before the period.
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- 21 USC 360n–1(a)
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