Supplement Industry Waits For “Friendlier” MedWatch Form
By
Malcolm Spicer / Email the Author / “The Tan Sheet” Jan. 2, 2012, Vol. 20, No. 01
Dietary Supplements / Word Count: 1132 / Article # 05120102008
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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