You might think that FDA’s Center for Veterinary Medicine (CVM) is the U.S. government agency that regulates and inspects biologics for animals. But regulation of biologics that affect or impact the immune system of animals, including inspections, falls under the U.S. Department of Agriculture (USDA) under its Animal and Plant Health Inspection Services (APHIS) agency, specifically the Center for Veterinary Biologics (CVB).
Recently, Redica Systems Senior GMP Expert Jerry Chapman provided a four-part overview into the USDA CVB’s authorities when it comes to regulating animal biologics such as rabies and distemper vaccines administered to dogs. He covered a presentation by USDA CVB Senior Biologics Specialist Kendall Graber at the virtual International GMP Conference in March, which delved deeply into CVB and how it regulates animal biologics.
Below are the four parts of this series.
- Inside USDA’s Center for Veterinary Biologics: Part I, Intro to CVB
- Inside USDA’s Center for Veterinary Biologics: Part II, 21 CFR, and 9 CFR Compared
- Inside USDA’s Center for Veterinary Biologics: Part III, A Deep Dive on 9 CFR Expectations
- Inside USDA’s Center for Veterinary Biologics: Part IV, Product Release, International Efforts
[Related: If you are a manufacturer of animal health drugs, consider trying out Redica Systems for free by clicking here.]
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