2 Veterinary Medicine Guidances Published

The Center for Veterinary Medicine has published two data element guidances. The first guidance, Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine, is to help applicants and non-applicants to complete form FDA-1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” The document says applicants must report adverse drug experiences and product/manufacturing defects on that form. It says the agency has revised form FDA-1932 as part of its effort to harmonize its adverse event regulatory reporting data elements with those of other nations as well as streamline reporting for product and manufacturing defects.

The second guidance, Pharmacovigilance of Veterinary Medicine Products: Electronic Standards for Transfer of Data, provides recommended standards to construct a single adverse event report electronic message to transmit to all Veterinary International Conference on Harmonization member regions and product problem reports to FDA for veterinary medicinal products.