FDA Competitive Generics Draft Guide Touts Exclusivity For Multiple CGTs

By Beth Wang / February 15, 2019 at 1:47 PM
FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs that have little-to-no competition on the market. Notably, FDA lays out how exclusivity will work under the CGT pathway, including giving exclusivity to multiple CGT pathway-approved drugs under certain circumstances. Although FDA Commissioner Scott Gottlieb touted the number of applications that...


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