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MedWatch forms continued

This article was originally published in The Tan Sheet

Executive Summary

FDA asks the Office of Management and Budget for a three-year extension of the MedWatch form for mandatory reports from firms marketing medical devices, Rx and OTC drugs and dietary supplements. In a Sept. 24 Federal Register notice, the agency says the instructions on the MedWatch form will be changed to reflect that AERs for OTCs and supplements now are mandatory (1"The Tan Sheet" Dec. 18, 2006, p. 4). No changes are proposed for "any content or formatting," the notice says. Dietary supplement industry stakeholders told FDA that the MedWatch form was developed for reporting pharmaceutical adverse events, but including all information relevant to some supplement-related events customers report will be difficult with the current form. The deadline for comments on the notice is Oct. 24

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