FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

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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

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Relevant Links:

• • PDUFA VII Commitment Letter
• • PDUFA Amendments
• • PDUFA Reauthorization Act
• • FDA-TRACK: PDUFA Performance Reports
• • FDA-TRACK: CDER Drugs and Biologics Dashboard

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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.

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Footnotes:

• ** 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).
• **** 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).

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