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October 10, 2025

GDUFA III Reauthorization

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality […]
October 10, 2025

GDUFA IV: Fiscal Years 2028 – 2032

In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the third reauthorization of the Generic Drug User Fee Amendments […]