SENTINEL INITIATIVE

In response to FDAAA, the FDA launched the Sentinel Initiative. The Sentinel Initiative aims to improve how FDA monitors medical product safety issues... The U.S. Food and Drug Administration (FDA) leads the Sentinel Initiative. FDA created the Sentinel Initiative to meet a mandate by Congress in the FDA Amendments Act of 2007. Through the Sentinel Initiative, FDA aims to develop new ways to assess the safety of approved medical products including drugs, vaccines, and medical devices.