October 8, 2014
The U.S. Food and Drug Administration issued a final guidance document today to help drug manufacturers submit accurate and consistent adverse event reports related to animal medicinal products, also known as animal drugs. The final guidance, GFI 143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms outlines the terms that should be used when submitting an adverse event report to FDA. This guidance complements GFI 188, “Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine,” which provides instructions for veterinary drug adverse event reporting. GFI 143 also includes steps to keep the lists of terms up to date.
Controlled lists of terms are important for assessing the safety and efficacy of veterinary medicinal products because they help ensure consistency and allow easier comparison between veterinary medicinal products and across product classes.