This article was originally published in The Tan Sheet
Executive SummaryFDA revises its estimate for annual mandatory adverse event reports related to dietary supplement products to 856 from 960, based on the 214 AERs it received between Jan. 1 and April 15, according to a Sept. 15 Federal Register notice. In a separate same-day notice, FDA announces it received no comments following an October 2007 notice about information collection provisions for nonprescription drug AERs. The agency's estimate for annual serious OTC AERs will remain at 12,500 from approximately 50 respondents
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