June 26, 2013
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced today the availability of CVM Internal Terms for use in veterinary adverse event reporting. These terms can be used voluntarily in conjunction with the Veterinary Dictionary for Drug Related Affairs (VeDDRA) terms to provide a comprehensive description of clinical events.
There are two sets of CVM Internal Terms: those that describe product or manufacturing defects, and those that include pathology, lack of effectiveness, and laboratory tests. CVM has published these lists in the Supporting Documents section of the Veterinary Adverse Event Reporting for Manufacturers webpage.
In July 2013, industry users of the Safety Reporting Portal will be able to choose from both the CVM Internal Terms and the VeDDRA terms. Users reporting through the Electronic Submissions Gateway will have access to these vocabulary choices when their company upgrades to the 2013 version. In the interim, users are encouraged to place the desired terms at the end of the event narrative.