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Animal and Plant Health Inspection Service
U.S. Department of Agriculture
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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. 

The proposed manufacturing and testing facilities must also meet the standard requirements as outlined in the 9 CFR, Part 108. Manufacturing facilities located in communal buildings, such as University Research Parks or New Business Incubator buildings may not meet the control and quality standards required for the manufacturing of a veterinary biological product. These shared spaces bring with them a host of issues not seen with a traditional manufacturing setting. A reminder to new applicants considering a communal manufacturing site; the entire building would be considered licensed premises and as such the entire building would be subject to inspection by the Center for Veterinary Biologics. 

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:

Guidance for New Firms

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