On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act of 2017 (FDARA). This law reauthorized the Generic
Drug User Fee Amendments (GDUFA), which is designed to speed access to safe and effective generic drugs to the public. GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.
The current legislative authority for GDUFA expires at the end of September 2022. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.
This page is a resource for keeping the public and stakeholders informed of recent developments related to the reauthorization of GDUFA.