GDUFA IV Reauthorization

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 (GDUFA). The current legislative authority for GDUFA III expires in September 2027. At that time,...

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 generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of...