Review of Updated Regulations and Product License Categories for Veterinary Vaccines in the United States

December 30, 2020 — 

The USDA continues to consider and implement regulatory pathways for evolving scenarios, needs, and technologies. The intent of this report is to make veterinarians and other users of veterinary biologics aware of recent regulatory additions and changes, particularly in the area of veterinary vaccines. These include new licensure pathways to increase product availability, standardization of labeling, and increased transparency regarding adverse event reports and the efficacy and safety studies accepted by the USDA for product licensure. This report did not undergo scientific peer review.

Erdman M, Clough N, Hauer P. Review of updated regulations and product license categories for veterinary vaccines in the United States. JAVMA. 2020 Dec. https://doi.org/10.2460/javma.2020.257.11.1142