Regulatory Brief

 Electronic data collection

Formal title: Docket Number [FDA-2008-N-0546] Agency Information Collection Activities; Proposed Collection; Electronic Data Collection Using MedWatchplus Portal and Rational Questionnaire


The Food and Drug Administration (FDA) announced its notice to solicit comments on the proposed collection of electronic data using MedWatch\Plus\Portal and Rational Questionnaire.

Brief Description and AVMA Response

The Food and Drug Administration (FDA) announced its notice for public comment on the proposed collection of adverse event reports and other safety information for all FDA-regulated products by the FDA.

The AVMA commends the FDA on its leadership and efforts to develop a user-friendly web portal through which health professionals and the general public may submit adverse events associated with FDA-regulated products. The AVMA believes a web portal would be a highly utilized resource by the AVMA membership and encourages the FDA to solidify development and to implement this web resource.

Moreover, the AVMA welcomes the opportunity to serve as a resource to the FDA, specifically by providing the FDA with veterinary medical feedback regarding the anticipated functionality of the new adverse events reporting porta.

Background Documents

View Federal Register document (PDF)

View AVMA's full response to FDA(PDF)


AVMA responded on December 22, 2008