ADUFA Archives

FY 2026 Animal Drug User Fees

By Rebecca Welton Jul 30, 2025 ADUFA FDA Fees Regulatory Affairs

Both pioneer and generic animal drug user fees have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY 2026 and AGDUFA FY 2026. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and Outsourcing. I’m sure that pioneer/innovator animal health companies are in a bit of shock over […]

Jul

The UFA’s FY 2021 Fee Adjustments Are Off and Running

By Bob Pollock Jul 30, 2020 ADUFA AGDUFAs FDA MDUFA PDUFA Regulatory Affairs User Fees

Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]