U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Generic Drug User Fee Amendments
  5. GDUFA II
  1. Generic Drug User Fee Amendments

GDUFA II

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This law included 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.

When GDUFA was reauthorized in 2017, FDA made the following commitments:

The legislative authority for GDUFA II expires at the end of September 2022. At that time, new legislation is required for FDA to continue to collect generic drug user fees for future fiscal years.

For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.

 

Back to Top