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Suggestions for New Biologics Applicants |
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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:
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Veterinary Services Memorandum 800.50 (PDF, 32KB)
Basic License Requirements and Guidelines for Submission of Materials in Support of Licensure -
Veterinary Services Memorandum 800.101 (PDF, 21KB)
U.S. Veterinary Biological Product Permits for Distribution and Sale (guidance specific to imported products) -
Veterinary Services Memorandum 800.73 (PDF, 36KB)
General Requirements for Immunodiagnostic Test Kits for the Detection of Antibody or Antigen (guidance specific to diagnostic test kits) -
Veterinary Services Memorandum 800.200 (PDF, 29KB)
General Licensing Considerations: Study Practices and Documentation -
Other "General Licensing Considerations" found in the "800.2XX" series of the Veterinary Services Memorandums
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