Cutting through the animal health regulatory alphabet

Here is our first contribution from Dr. Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory affairs. Dr. Hunter shares some background, resources and anacronyms for both the novice and experienced animal health industry professionals.


For the past 3 years, K-State Olathe has provided various seminars on topics relevant to the animal health regulatory environment both for biologics and pharmaceuticals. In many of these, the regulatory agencies involved have actively participated. Based on feedback and input from these seminars and the industry, several recurring workshops were developed to support continuing education of industry stakeholders. The first, titled “Animal Health Regulatory 101,” was held in November of 2019. This 2-day workshop covered FDA/CVM (Food and Drug Administration/Center for Veterinary Medicine), USDA/CVB (United States Department of Agriculture/Center for Veterinary Biologics), and a small bit on EPA (U.S. Environmental Protection Agency) product approvals at a high level (+30,000 ft). It has since been offered two additional times with more than 90 people participating so far from across the US and 5 international countries.

In October of 2020, K-State Animal Health Instructor Norm Brown, along with Terrie Jo Hamtak with Merck Animal Health, and Helen Smith with Ceva Biomune, provided a detailed course on the specifics of biologics registration with USDA/CVB. Lastly, Stephanie Batliner with Bimeda; independent consultant Dr. Karen Fuller, and myself conducted a 2-day advanced pharmaceutical workshop in November 2020. The workshop covered the topics of CMC (Chemistry, Manufacturing and Control), safety, and efficacy of the veterinary drug approval process. Both introductory and advanced workshops were well attended and will be offered again in the first half of 2021.

I would now like to share a quality and easily accessible resource to help stay up to date with Federal Agency news and information through the email subscription service, GovDelivery. It provides updates on CVM’s latest thinking by announcing CFR (Congressional Federal Register) publications and new Guidance for Industry (GFIs). The service also allows a person to subscribe to emails that provide updates to CFSAN (Center for Food Safety and Nutrition), CDER (Center for Drug Evaluation and Research), CBER (Center for Biological Evaluation and Research), CVM, drug shortages, warning letters, etc., which is useful information for anyone involved with the industry. It also allows subscription to USDA updates. The USDA subscriptions cover commodity imports and exports, FSIS (Food Safety and Inspection Service) residue violations, CVB, Animal Welfare violations, and various other topics. These email subscriptions are an easy way to stay ahead of the curve when it comes to U.S. government regulations. You can subscribe here.

Why provide this information to the savvy reader of this blog? It gives a basis to talk about changes and announcements in the US regulatory environment. We hope in the coming weeks to provide perspectives on several current and relevant topics to the Animal Health Pharmaceutical (FDA/CVM) and Biological (USDA/CVB) industry.

I have tried to define the abbreviations as they appeared in this blog, but some others that might be of use to the readers of this blog: ADUFA (Animal Drug User Fee Act), AGDUFA (Animal Generic Drug User Fee Act), AMDUCA (Animal Medicinal Drug Use Clarification Act), MUMS (Minor Use Minor Species Act) are just a few to mention. I will continue to add to this in future blogs. I also plan to discuss the current Draft GFI # 256 (Bulk Compounding), Dissolution and Biowaivers, and COVID plant inspections and the impact of these topics in the near future. We welcome readers input and suggestions on future blog topics.

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