FDA Continues Implementation of `Sentinel’ Work on Safety

The FDA is still working on implementing its “sentinel” system to track the safety of drugs and other FDA-approved products, attorneys told Bloomberg BNA recently.

The Sentinel Initiative, a rapid-response electronic safety surveillance system for medical products, was created as part of the Food and Drug Administration Amendments Act of 2007. The FDA officially launched the Sentinel pilot program in 2008 6 PLIR 632, 5/30/08, 2 LSLR 459, 6/6/08, 7 MRLR 341, 6/4/08. The agency describes Sentinel as a national electronic system “that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices once they ...