💊New FDA Prescription Drug User Fee Rates for FY 2026
Prescription Drug User Fee Rates for Fiscal Year 2026
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for prescription drug user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2026.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation outlines new prescription drug user fee rates set to impact the costs for businesses in the pharmaceutical sector, effective from October 1, 2025. Businesses must budget for these increased application fees, which are a significant operational cost. The total revenue generated affects overall pricing strategies and compliance with regulatory requirements.