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Federal regulatory practice issues: Drugs

Electronic data collection
Formal title:
Docket No. FDA–2008–N–0546 - Electronic Data Collection Using MedWatch\Plus\ Portal and Rational Questionnaire

View Federal Register document (PDF)

Action

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.

Response
View AVMA's full response to FDA (PDF) (December 22, 2008)
Status
AVMA responded on December 22, 2008
 


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