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Suggestions for New Biologics Applicants

New applicants are encouraged to contact the Center for Veterinary Biologics (CVB) early in the product development process. A licensing reviewer will be assigned to help you through the regulatory process. Initially, the CVB will confirm that the proposed product meets the definition of a veterinary biologic and is subject to regulation by the CVB. We then recommend that applicants submit a licensing plan, including pivotal study protocols, to the CVB for review and comment prior to initiating work that will be used to support product licensure.

A complete listing of the regulations and guidance documents pertinent to veterinary biologics is found on the CVB's Program Regulations and Guidance page. We encourage new applicants to read the following documents in particular: