Generic Drug User Fee Amendments II Implementation Activities
Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe and high quality generic drugs and generic drug products. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. GDUFA was reauthorized on August 18, 2017 (GDUFA II), with provisions that went into effect October 1, 2017 and remain in effect through September 30, 2022.
The webpages listed below, along with the GDUFA II commitment letter, feature information about GDUFA implementation activities, and provide transparency on the progress and performance of FDA’s generic drugs program.
- Submission Review
- ANDA Review Enhancements
- Pre-ANDA Program & Complex Generic Products
- Drug Master File (DMF) Review Enhancements
- Facilities Enhancements
- Enhanced Accountability & Reporting
FDA has created a series of videos highlighting new features in GDUFA II. The video below provides an overview of GDUFA: