Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports

The Food and Drug Administration (FDA) is amending its regulations on expedited reporting of postmarketing adverse experiences to revoke the requirement for increased frequency reports as expedited reports for human drug and licensed biological products. This action, which is part of the President's regulatory reinvention initiative, is based on FDA's determination that expedited increased frequency reports have not contributed to the timely identification of safety problems requiring regulatory action and are no longer necessary for FDA surveillance of postmarketing adverse experiences. This action is intended to streamline postmarketing expedited reporting of adverse experiences for human drug and licensed biological products. This action will not affect the requirement for expedited reporting of all serious, unexpected adverse experiences.