Issue Date: January 31, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Adverse Event Reporting
Status: Final
CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
The purpose of this guidance is to assist applicants (referred to as Marketing Authorization Holder (MAH) in this guidance) and nonapplicants with filling out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” As required by Food and Drug Administration (FDA) regulations at 21 CFR 514.80, an applicant must report adverse drug experiences (ADEs) and product/manufacturing defects on Form FDA 1932. Firms named on the label as a manufacturer, packer, or distributor may also use this form.
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