FDA requires registration of facilities for everything from animal/veterinary and human drugs, medical devices, cosmetics, food, tobacco, radiation-emitting products, and vaccines, blood, and biologics. This blog focuses on the Drug Establishment Registration (DER) requirements. On September 25, 2026, a whirlwind of emails came through to those of us in the pharmaceutical world proclaiming that the […]
For those of us in the Animal Drug world, we know it is unusual to hear much regarding compounding of animal drugs. Generally speaking, Animal Drug Compounding is prohibited; in accordance with GFI #256, “animal drugs compounded from bulk drug substances by pharmacists and veterinarians do not meet certain important requirements of the Federal Food, […]
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 […]
