The U.S. Food and Drug Administration’s Center for Veterinary Medicine, or FDA/CVM, is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products — including licensed biologics, such as vaccines — is shared with other federal agencies.
For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service, or APHIS, and products such as flea and tick collars are regulated by the Environmental Protection Agency, or EPA. This makes navigating the regulatory space a bit confusing for people new to the industry or who have worked in the area of human drug development.
This workshop on veterinary medicine regulations will provide attendees with an understanding of veterinary drug approval processes. This two-day interactive course will cover a series of learning objectives.
This course will assist with connecting EMA, APVMA and VDD Animal Health drug registration requirements to CVM/FDA. It will help current international regulatory affairs personnel relate and understand the similarities and differences between non-US and US regulatory bodies.