FDA-TRACK: Prescription Drug User Fee Act Procedural 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

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.