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

The FDA has just unveiled its new user fee rates for drugs, devices, generic drugs, over-the-counter medicines, biosimilars, and compounding outsourcing facilities. We break it down.

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Today’s Federal Register includes pre-published notices announcing the FDA’s user fees for Fiscal Year 2025, which apply from October 1, 2024, through September 30, 2025. While we’re waiting to see user fee rates for priority review vouchers, the following rate documents have been unveiled:

• Prescription Drug User Fee Rates for Fiscal Year 2025

• Medical Device User Fee Rates for Fiscal Year 2025

• Generic Drug User Fee Rates for Fiscal Year 2025

• Over-the-Counter Monograph Drug User Fee Program: Over-the-Counter Monograph Order Requests Fee Rates for Fiscal Year 2025

• Biosimilar User Fee Rates for Fiscal Year 2025

• Outsourcing Facility Fee Rates for Fiscal Year 2025

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

• Prescription Drug Program Fee: $403,889

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:

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Medical Device User Fee Rates for FY 2025

Application Fees

• Premarket application (PMA, PDP, BLA):

  • Standard Fee: $540,783

  • Small Business Fee: $135,196

• Premarket report:

  • Standard Fee: $540,783

  • Small Business Fee: $135,196

• Efficacy supplement (to an approved BLA):

  • Standard Fee: $540,783

  • Small Business Fee: $135,196

• Panel-track supplement:

  • Standard Fee: $432,626

  • Small Business Fee: $108,157

• De novo classification request:

  • Standard Fee: $162,235

  • Small Business Fee: $40,559

• 180-day supplement:

  • Standard Fee: $81,117

  • Small Business Fee: $20,279

• Real-time supplement:

  • Standard Fee: $37,855