Future of Drug Safety - Promoting and Protecting the Health of the Public: FDA's Response to the Institute of Medicine's 2006 Report [open pdf - 434KB]
This report from the Food and Drug Administration (FDA) was written in response to the Institute of Medicine's (IOM) 2006 Report assessing the U.S. drug safety system. Specifically, this report addresses the FDA's commitment to drug safety and the IOM's recommendations in the context of the FDA's ongoing drug safety initiatives. In this report, the FDA sets forth their commitment to transforming the drug safety system, the actions they have taken or plan to take to fulfill this commitment, and their responses to the IOM recommendations. The report is organized around the following three themes: (A) The science supporting our drug product safety system; (B) Communication and information flows; and (C) Operations and management.
U.S. Food and Drug Administration: http://www.fda.gov/