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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Prescription Drug User Fee Act Meeting Management

 

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FDA-TRACK: CDER
FDA-TRACK: Biologics
PDUFA Performance Dashboard User Guide
FDA-TRACK Home Page

Prescription Drug Applications and Supplements

Procedural Notifications and Responses

Meeting
Management

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 Meeting Management Dataset

Footnotes:

  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for PDUFA VII (see Changes for this Goal, pages 20-27).
  • *** The most recent FY workload and performance data includes meetings where the type cannot be initially determined.

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