FDA Announces the Availability of Electronic Submissions for Animal Drug Adverse Events and Revised Reporting Forms
May 24, 2010
The Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced today the launch of an upgraded database that enables manufacturers to electronically submit mandatory reports of adverse drug events. CVM is also announcing the availability of revised versions of Forms FDA 1932 and 1932a, “Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report".
CVM developed and implemented a pharmacovigilance program that accepts reports electronically and pre-populates CVM’s database for adverse drug events, because electronic submission is a more efficient method of processing the large volumes of adverse event information submitted to CVM. CVM will be able to process information more efficiently and better address issues affecting animal health and safety.
Electronic submission of adverse event information will be possible through CVM’s Electronic Submissions System (ESS), which integrates with the FDA Electronic Submissions Gateway (FDA ESG) to allow adverse drug event reports, either individually or in batches, to be transmitted directly from industry to CVM (i.e., gateway-to-gateway submission).
FDA has also revised the form for mandatory reporting of adverse drug events for manufacturers, Form FDA 1932. A transitional period of approximately six months will allow companies time to accommodate the revisions, as they may require changes to validated databases. During this time, both versions of Form FDA 1932 will be available. After this transitional period, only the revised version of the form will be available for use.
In addition, a revised version of Form FDA 1932a for voluntary reporting of adverse event information from private individuals, consumers, or healthcare professionals is now available.
A draft Guidance for Industry is available with instructions on how to complete Form FDA 1932, regardless of the method of reporting (i.e., paper or gateway-to-gateway submission).