FDA-TRACK: Generic Drug User Fee Amendments (GDUFA) Quarterly Performance Dashboards
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Generic Drug Applications and Supplements
GDUFA was enacted on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), and was most recently reauthorized on September 30, 2022, extending the program through September 30, 2027. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA's generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications.
The Generic Drug User Fee Amendments Performance Quarterly Dashboards (GDUFA Quarterly Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated GDUFA Performance Report to Congress for the Generic Drug User Fee Amendments (the Report). The GDUFA Quarterly Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The charts in the GDUFA Quarterly Dashboards present GDUFA goal performance for three fiscal years (FY), FY 2024 - FY 2026. While FY 2024 data is considered final, FY 2025 and FY 2026 data are preliminary and updated on a quarterly basis. Final GDUFA performance data for FY 2025 will be presented in the FY 2026 GDUFA Report and referenced in updated versions of the GDUFA Dashboards.
Generic Drug Applications and Supplements
The Generic Drug Applications and Supplements Dashboard displays current performance relating to the review of:
- Standard and Priority Original Abbreviated New Drug Application (ANDA) Submissions
- Standard and Priority Major and Minor ANDA Amendments
- Standard and Priority Prior Approval Supplements (PAS)
- Standard and Priority Major and Minor PAS Amendments
- Unsolicited ANDA and PAS Amendments
- Completeness Assessments of Type II Active Pharmaceutical Ingredient Drug Master Files
- Level 1 and 2 Controlled Correspondence (CC)
- Submitter Requests to Clarify Ambiguities in the CC