The U.S. Senate has passed H.R. 2430, the FDA Reauthorization Act (FDARA). This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revises FDA user fees for new drug applications.   PBOA president Gil Roth said, “Our members commend the Senate for its passage of the FDA Reauthorization Act, including the Generic Drug User Fee Amendments. GDUFA II will not only empower FDA and industry to work toward swifter approval of cost-lowering generic drugs, it will also em...