FDA-TRACK: Generic Drug User Fee Amendments (GDUFA) Performance Dashboards
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Generic Drug Applications and Supplements
Program Enhancement Goals (Procedural)
Meeting Management
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 Dashboards (GDUFA 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 Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The GDUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2025. The GDUFA Dashboards present updated performance in meeting GDUFA goals for FY 2024 and preliminary performance for FY 2025. Updated 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
Program Enhancement Goals (Procedural)
The Program Enhancement Goals (Procedural) Dashboard displays current performance relating to the review of/responses to:
- Assessment Classification Changes During Assessment Cycle
- Dispute Resolutions
- Suitability Petitions
- Product-Specific Guidance (PSG) for Complex and Non-Complex Drug Products
- Foreign Regulators
- Re-Inspections
Meeting Management
The Meeting Management Dashboard displays current performance relating to the responses to/issuance of:
- Product Development Meetings
- Pre-Submission Meetings
- PSG Teleconference and Meetings
- Mid-Cycle Review Meetings (MCRM) and Enhanced MCRMs
- Post-Complete Response Letter (CRL) Teleconference Meetings
- Post-CRL Scientific Meetings
- DMF First Cycle Review Deficiency Teleconferences
- Post-Warning Letter (WL) Meetings