FDA Expands Medical Device Surveillance Program

After five years, the FDA is transitioning its Mini-Sentinel program to a full-scale Sentinel System.  “We’re on our way to developing a nationwide rapid-response electronic active surveillance system, Sentinel System, for monitoring the safety of FDA-regulated drugs and other products,” wrote Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a recent blog post.

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