Supplement Industry Waits For “Friendlier” MedWatch Form

This article was originally published in The Tan Sheet

02 Jan 2012
News

Malcolm Spicer @TheTanSheet malcolm.spicer@informa.com

Executive Summary

FDA changes MedWatch form 3500A to accommodate medical device firms’ needs, but will not make changes to facilitate reporting AERs for drug, supplement or food products. The agency and supplement industry stakeholders agree 3500A is not ideal for supplement AERs.

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Supplement Industry Waits For “Friendlier” MedWatch Form

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Executive Summary

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