The Animal Drug User Fees for both Pioneer and Generics applications have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY2027 and AGDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, and Outsourcing. As a reminder, ADUFA V (FY2024-FY2028) allows for an adjustment for inflation and […]
While most of us were sleeping, the ICH has been busy revising nine of its guidances titled International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics for different species. The prepublication of the Federal Register today (here, please scroll down to regular filings on the lefthand side of […]
The FDA announced the Generic Animal Drug User Fee Rates for FY 2022 in today’s Federal Register here. This will be a first in an avalanche of announcements of new User Fee rates for the coming FY. The rates for Generic Animal Drugs for FY 2022 are provided in the table below: Fee Category […]
