AER guide
This article was originally published in The Tan Sheet
Executive Summary
The Institute for Health Research is publishing an Adverse Events Reporting guide for marketers of natural products and dietary supplements who use neutral third-party AE screening companies in order to meet the standards suggested by FDA's draft AER guidance, the institute announces Oct. 13. Available online at AER-Consulting.com, the guide will also be "invaluable in the future to determine drug and non-pharmaceutical interactions," the NGO adds. FDA's Center for Food Safety and Applied Nutrition posted the draft guidance on its Web site Oct. 11; the law goes into effect Dec. 22 (1"The Tan Sheet" Oct. 15, 2007, p. 4)...