Sec. 4. Requiring demonstration of superior outcomes for qualified infectious disease products To receive an extended exclusivity period
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Section 505E(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f(g) ) is amended by striking means an antibacterial or antifungal drug for human use intended to treat and inserting means an antibacterial or antifungal drug for human use that is demonstrated to produce superior outcomes over available therapies, based on direct measures of patient benefits in clinical trials, and that is intended to treat .
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Sec. 4
Requiring demonstration of superior outcomes for qualified infectious disease products To receive an extended exclusivity period
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