Enhanced Accountability & Reporting
In order to promote accountability and transparency, GDUFA II includes provisions so that industry and public stakeholders are able to observe the Agency’s productivity and performance with generic drug reviews under GDUFA II.
The links below provide data on GDUFA metrics and are updated periodically:
Activities Reports of the Generic Drug Program
- Monthly Performance Report of the Generic Drugs Program
- Quarterly Performance Report of the Generic Drugs Program
Additional Reports
- Performance Reports
- Financial Reports
- FDARA Quarterly Report of Generic Drugs Program Activities (additional FDARA reports available here)
- GDUFA Section 903 Quarterly Report of Generic Drugs Guidances and Public Meetings
- Quarterly Meeting Minutes Between FDA and Industry
- Bi-Annual Industry Regulatory Science Work Group Meeting Minutes