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.
This article is only available in full to paid subscribers. If you’re not already a paid subscriber, you can upgrade here.
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:
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:
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