CRN Proposes Dietary Supplement AE Reporting System Restructuring
This article was originally published in The Tan Sheet
Executive Summary
A new structure for FDA's adverse event reporting system that involves notifying marketers soon after an AE report involving their product has been posted on the agency's Web site, and the omission of company and product names from initial reports was proposed by Council for Responsible Nutrition VP-Scientific and Regulatory Affairs Annette Dickinson, PhD, at a May 27 hearing before the House Government Reform Committee.