Prescription Drug User Fee Rates for Fiscal Year 2026

https://www.federalregister.gov/documents/2025/07/30/2025-14413/prescription-drug-user-fee-rates-for-fiscal-year-2026?utm_medium=email&utm_source=govdelivery The annual FY 2026 PDUFA program fee invoices were emailed on Monday August 18, 2025. Please note that the invoices are only sent to firms with PDUFA user fee eligible products. If you do not receive your FY 2026 program fee invoice by August 22, 2025, and believe you should receive an invoice, please contact PDUFA User Fee staff at CDERCollections@fda.hhs.gov. Please note that the FY 2026 payment is due on October 1, 2025. The FY 2026 PDUFA fee rates were published in the Federal Register (FR) on July 30, 2025. The fee rates for FY 2026 are shown below: