FDA's Sentinel Project Advances from Pilot Stage

September 24, 2014 | The Sentinel Initiative, launched in 2008, aims to collect adverse event reports from electronic health records and insurance claims databases, giving the FDA an additional tool to monitor the safety characteristics of drugs and medical devices after they reach the market. (See "Sentinel Initiative Boosts FDA Safety Oversight.") Now, the first implementation of that program, called Mini-Sentinel, has been given the green light after a five-year pilot phase. Mini-Sentinel tracks EHR records from 18 healthcare systems around the country, covering nearly 180 million patients, and has already contributed to drug safety updates. Nature News