Summary of adverse event reports for veterinary biologic products received by the USDA from 1999 through 2005

摘要

In the United States, veterinary biologies and veterinary drugs are under the jurisdiction of separate government agencies. Veterinary vaccines and other biologic products are regulated by the USDA,a whereas veterinary drugs are regulated by the FDA.The Center for Veterinary Biologies (CVB) is the primary unit within the USDA that implements the provisions of the Virus-Serum-Toxin Act to ensure that veterinary biologic products are pure, safe, potent, and effective. Although evaluated for safety before licensure, not all potential safety issues can be addressed before a veterinary biologic product is released to the market. Prelicense safety studies may not detect safety concerns because of an insufficient number of animals for low-frequency events, insufficient duration of observation, sensitivities of subpopulations (eg, breed, reproductive status, or use in an unintended species), or concomitant administration of products. Therefore, it is important to gather information on how a product performs under conditions of use.