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  1. FDA-TRACK: Agency-wide Program Performance

PDUFA Prescription Drug Applications and Supplements



  • * Performance is currently preliminary due to pending submissions.
  • ** FY 2021 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. Undesignated submissions are excluded when calculating Highest Possible Final Performance and Goal Met Status.

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