FDA moves to full-scale Sentinel program

December 31, 2014

Agency kicks medical product safety-monitoring into a higher gear.

Following the successful completion of the five-year Mini-Sentinel program, FDA has announced, it is making a transition to the full-scale Sentinel System, a medical product safety-monitoring program that employs active surveillance.

The agency is planning a Feb. 5 meeting for stakeholders to review the transition to the full Sentinel System, the future of the system, and ongoing and emerging Sentinel projects. The Sentinel public event will be held at the Washington Plaza Hotel in Washington, D.C., and broadcast via a live webinar.

FDA Mini-Sentinel pilot launches

The FDA’s Mini-Sentinel pilot program that started in 2009 provided researchers with valuable safety information from electronic health records of more than 178 million Americans. This information has helped to enhance FDA’s safety surveillance capabilities, said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research.

“Over many years, FDA’s program that we now call FAERS [FDA Adverse Event Reporting System] has been our main tool for assessing the safety of medical products. This system relies on patients, medical professionals, and product manufacturers to report to us potential safety issues of the products FDA regulates,” Woodcock wrote in the FDA Voice blog.

“FAERS is an invaluable asset, and we’re not seeking to replace it. However, the Sentinel System offers us the exciting possibility of not waiting for safety information to come to us in the form of reports, but rather it enables us to go out and get that information, adding greatly to our safety-monitoring capability,” she said.

For more information and to register for the Feb. 5 event, click here.