Joint FDA-NIH Adverse Events Portal Being Developed

Top officials of the Food and Drug Administration and the National Institutes of Health, sister agencies within HHS, have signed an agreement to work together on a joint Web site for reporting adverse events and recalls. The document was posted Dec. 21 on FDA's popular MedWatch site, www.fda.gov/medwatch/, which is being updated into MedWatchPlus, according to the agreement.

The updated MedWatch will be a "portal through which adverse event, consumer complaint, and product problem reports are received and processed to make the information available to adverse event analysis systems," the document says. FDA and NIH agreed to collaborate on development of a "Rational Questionnaire" and a prototype to test the feasibility of a joint portal that allows users to utilize many forms both agencies employ. The "Rational Questionnaire" is described as an interactive help system to assist reporters of information.

The agreement was signed Sept. 27 by Dr. Janet Woodcock, deputy commissioner, chief medical officer in the FDA Office of the Commissioner, and Lana Skirboll, Ph.D., director for science policy in the NIH Office of the Director.

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