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FDA financial report to Congress on PDUFA, FY 2025

The FDA's annual report on the prescription drug user fees, with five-year tables of costs and funding sources.

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2025

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  1. 2025 FDA financial report to Congress on PDUFA, FY 2025
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  1. Financial Report to Congress: Prescription Drug User Fee Amendments, FY 2025, U.S. Food and Drug Administration. Primary record
    Historical Prescription Drug Activity Obligations by Funding Source
    74% 76% 74% 78% 77%
    PDUFA fees may be expended only for costs to support the “process for the review of human drug applications,”
    The spending trigger was $287,573,564 for FY 2025, less than the $398,956,452 for non-user fee appropriations obligated for FY 2025, meaning the trigger was met.
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