Key Reports on FDA's Safety Efforts
The Food and Drug Administration works to ensure that safe and effective medical products are available to the American public. FDA regulates a number of medical products, including over-the-counter (OTC) and prescription (Rx) drugs, therapeutic biologics, generic drugs, and medical devices. Periodically, FDA produces reports (e.g., to the public announcing a new initiative, in response to a congressional request) that describe FDA's safety-related efforts. Key reports on medical product safety efforts at FDA are available on this Web page.
- FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications, November 2009
Report announcing FDA's Safe Use Initiative to reduce preventable injuries from medication use by identifying specific, preventable medication risks and developing, implementing, and evaluating cross-sector interventions with partners who are committed to safe medication use.
- Report on FDA's Approach to Medical Product Supply Chain Safety (PDF - 302KB), July 2009
FDA Report to Congress
- Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System (PDF - 429KB), July 2009
FDA report to Congress and update on its January 2007 (see below) response to the IOM report. Includes a separate Attachment (IOM Recommendations: FDA Actions Update )
- The Future of Drug Safety - Promoting and Protecting the Health of the Public (PDF - 433KB), January 2007
FDA Response to the Institute of Medicine’s 2006 Report The Future of Drug Safety: Promoting and Protecting the Health of the Public (Institute of Medicine), which resulted from an FDA request to evaluate the nation's drug safety system Managing the Risks from Medical Product Use: Creating a Risk
- Managing the Risks from Medical Product Use: Creating a Risk Management Framework, May 1999
Report to the Commissioner from the FDA Risk Management Task Force