FDA Issues Guidance Document to Address Adverse Event Reporting of Veterinary Drugs

May 10, 2006 — 

The U.S. Food and Drug Administration (FDA) has issued a draft revised guidance for industry entitled "Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)".

This guidance document has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to describe the reporting system for identification of possible adverse events following the use of marketed veterinary medicinal products (VMPs) submitted to the European Union, Japan, and the United States.

For further information contact: Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9062, e-mail: lynn.post@fda.hhs.gov.

Source:
Federal Register: Volume 71, Number 84
[Page 25846-25848]
[DOCID:fr02my06-79]
[Docket No. 2000D-1632 (formerly 00D-1632)]