In order to promote accountability and transparency, GDUFA II included provisions so that industry and public stakeholders are able to observe the Agency’s productivity and performance with generic drug reviews under GDUFA II. Please note GDUFA III began in October 2022.

The links below provide data on GDUFA II metrics:

GDUFA II Activities Reports

• Monthly Performance Report of the Generic Drugs Program (FY22)
• Quarterly Performance Report of the Generic Drugs Program (FY22)

Additional Reports

• GDUFA III Monthly and Quarterly Reporting (FY 23 – 27)
• 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