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:

• GDUFA II Implementation Activities
• GDUFA II Submission Review
• GDUFA II ANDA Review Enhancements
• GDUFA II Pre-ANDA Program
• GDUFA II Drug Master File (DMF) Review Enhancements
• GDUFA II Facilities Enhancements
• GDUFA II Enhanced Accountability and Reporting
• GDUFA II Videos and Resources

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.