U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Generic Drug User Fee Amendments
  5. GDUFA Legislation
  1. FDA User Fee Programs

GDUFA Legislation

GDUFA Legislation

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA).  This new law includes the Generic Drug User Fee Amendments of 2012 (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.