FDA-TRACK: Prescription Drug User Fee Act Procedural Notifications and Responses

 

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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. • 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 PDUFA Procedural Notifications and Responses Dataset

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Footnotes:

• * Performance is currently preliminary due to pending submissions.
• ** New Performance Goal for PDUFA VII with performance tracking beginning in FY23 (see Changes for this Goal, page 35 for Human Factors Protocol to INDs and pages 12-13 for Priority and Standard NME NDA and Original BLA PMRs).
• *** New Performance Goal for PDUFA VII with performance tracking beginning in FY24 (see Changes for this Goal, page 34 for Use-Risk Related Analysis and and page 44 for REMS Assessment Methods and Protocols).