CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
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Guidance Issuing OfficeCenter 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.
As part of FDA’s ongoing effort to harmonize the Agency’s adverse event (AE) regulatory reporting data elements with those of other nations as well as streamline reporting for product and manufacturing defects, FDA revised Form FDA 1932. The changes to Form FDA 1932 are the product of discussions undertaken between the United States, Japan, and the European Union as part of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). FDA revised Form FDA 1932 to bring the AE reporting data elements on the form more in line with the data elements developed as a result of the VICH discussions.4 In addition, the Agency has included new data elements to gather information specific only to the FDA. This information will enable FDA to process and review electronic and paper reports.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0241.