FDA-TRACK: Prescription Drug User Fee Act Performance Prescription Drug Applications and Supplements

 

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Prescription Drug Applications and Supplements

Procedural Notifications and Responses

Meeting
Management

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

Relevant Links:

1. • PDUFA VII Commitment Letter
2. • PDUFA Amendments
3. • PDUFA Reauthorization Act
4. • FDA-TRACK: PDUFA Performance Reports
5. • FDA-TRACK: CDER Drugs and Biologics Dashboard

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to assess and collect fees for prescription drug products from October 2023 through September 2027. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities.

Download Prescription Drug Applications and Supplements Dataset

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Footnotes:

• * FY 2025 and FY 2026 includes preliminary performance as of 12/31/2025.
• ** Beginning in PDUFA VII, Class 1 and 2 Resubmitted Original Applications are consolidated into one performance goal. To review the number Filed, On Time, and Overdue for Class 1 and Class 2 resubmitted applications separately, please refer to the FY 2025 PDUFA Performance Report for the FY 2024 data. The FY 2025 and FY 2026 data will be available in the FY 2026 PDUFA Performance Report (See Changes for this Goal, footnote 3, page 6).
• *** The most recent FY workload and performance data includes applications that are identified as undesignated, which means they are still within the 60-day filing date and have not yet had a review designation, standard or priority, made.
• **** Beginning in PDUFA VII, Class 1 and 2 Resubmitted Efficacy Supplements are consolidated into one performance goal. To review the number Filed, On Time, and Overdue for Class 1 and Class 2 resubmitted efficacy supplements separately, please refer to the FY 2025 PDUFA Performance Report for the FY 2024 data. The FY 2025 and FY 2026 data will be available in the FY 2026 PDUFA Performance Report (See Changes for this Goal, footnote 4, page 6).