The FY 2026 user fees have been announced! The Federal Register (FR) Notice related to Prescription Drug User Fees (PDFUA) can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, MDUFA, and ADUFA.
The fees increased by 8.6% for applications, which is a larger increase when compared to that from FY 2024 to FY 2025, which was about a 6.5% increase. Program fees increased by 9.5% for FY 2026, which is a significant change when one realizes that they decreased between FY 2024 and FY 2025.
1Not orphan drugs
As stated in FR Notice, the new user fees will be effective on October 1, 2025. The FDA will issue invoices for payment of FY 2026 program fees under the new fee schedule in August 2025. The FDA will issue invoices in December 2026 for products that qualify for FY 2026 program fees after the October 2025 billing.
As our readers are aware, the user fees are assessed based on the projected workload. In the FR notice, Tables 6 and 7, the FDA shared the CDER and CBER forecasted workloads for FY 2026 compared to actual workloads from FY 2024, as shown below.
1New Drug Applications (NDA)/Biological License Applications (BLA).
2Written responses only (WROs).
3For purpose of the CPA, this is defined as an active commercial Investigational New Drug (IND) for which a document has been received in the past eighteen months.
4Represents activities related to the review of materials submitted to the application file after approval.
5Represents the percentage of active risk evaluation and management strategy (REMS) programs proportional to Center and User Fee by total number of qualifying products with the exclusion of the Opioid Shared System.
