FDA Prescription Drug User Fee Act (PDUFA) reauthorization and user-fee share of drug review (CRS R42508) (2023)

Government Record · Congressional Research Service · 2023

CRS's PDUFA report documenting that industry user fees fund more than 60% of FDA's human drug review budget (per FDA official testimony), the structural funding link between industry and the regulator.

user fees have come to provide more than 60% of FDA's drug review budget

CRS's PDUFA report documenting that industry user fees fund more than 60% of FDA's human drug review budget (per FDA official testimony), the structural funding link between industry and the regulator. CRS attributes the share figure to FDA testimony; the report also describes the statutory framework and reauthorization history.

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