GDUFA III Reauthorization
Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. 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 September 30, 2022 (GDUFA III), with provisions that are in effect from October 1, 2022, through September 30, 2027.
The webpages listed below, along with the GDUFA III commitment letter, feature information about GDUFA III implementation activities and provide transparency on the progress and performance of FDA’s generic drugs program. These pages include recorded presentations, policy documents and other resources that highlight program changes, enhancements and new information in GDUFA III for current and prospective abbreviated new drug application (ANDA) applicants and others interested in generic drug development and regulation. These pages will be updated as more information becomes available throughout the implementation of GDUFA III.
- Pre-ANDA Program
- ANDA Assessment Program
- Controlled Correspondence
- Drug Master File (DMF) Assessments
- Changes for Facilities
- User Fee Resource Management Program
- Monthly and Quarterly Activities Report
Questions about GDUFA III? Current and prospective ANDA applicants should contact firstname.lastname@example.org. All others with inquiries should contact email@example.com.
- Generic Drug User Fee Amendments
- GDUFA Guidances and MAPPs
- ANDA Forms and Submission Requirements
- Pre-ANDA Program for Complex Generic Products
- GDUFA II Videos and Resources