FDA begins shift to full-scale Sentinel system

FDA is beginning the transition from a pilot program to a full-scale version of its Sentinel system, an active surveillance system with which it can query electronic health records to identify and monitor postmarket safety. FDA spokesperson Tara Goodin would not tell BioCentury the launch date.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), wrote in a blog post that Sentinel will complement rather than replace the agency's FDA Adverse Event Reporting System (FAERS), a passive surveillance system. ...