In Brief: FDA Adverse Event Reporting System
Executive Summary
FDA Adverse Event Reporting System: Public meeting on March 17 will address electronic submission of postmarketing adverse drug reaction reports under FDA's adverse event reporting system. FDA will explain at the meeting how standards contained in International Conference on Harmonization guidelines on safety data relate to agency reporting requirements. The meeting will be held at the DoubleTree Hotel in Rockville, Md. beginning at 9:30 a.m...