The FDA's Fiscal Year 2025 User Fees: A Quick Guide

We’ve broken down each of these user fee documents below to provide a more convenient distillation of the fees for each type of entity.

Prescription Drug User Fee Rates for FY 2025

Fee Schedule for FY 2025:

• Application Fees :
  • Requiring Clinical Data: $4,310,002
  • Not Requiring Clinical Data: $2,155,001

  Summary of the Calculation Process:

  • Base Revenue Amount : $1,358,764,346.
  • Adjustments :
    • Inflation Adjustment: $55,936,252.
    • Strategic Hiring and Retention Adjustment: $4,000,000.
    • Capacity Planning Adjustment: $1,522,700.
    • Additional Dollar Amount: $14,154,169.
    • Operating Reserve Adjustment: $5,007,412.
    • Additional Direct Cost: $39,355,553.

    Total Revenue Amount after Adjustments:

    • Final Total Revenue : $1,478,740,000.

    For more detailed information, refer to the full document: