Sentinel Pilot Begins Scanning Drug Data, But Device Work Still Exploratory
This article was originally published in The Gray Sheet
FDA will implement its mini-Sentinel post-market safety surveillance program for the first time, using data from an ongoing randomized trial of a diabetes drug.
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Funds for FDA’s Mini-Sentinel post-market surveillance program were originally capped at $100 million based on projections for a consortium of at least three automated health care data partners to build analysis capabilities for data covering 100 million patients. The project has significantly exceeded those goals.
FDA hopes the MDEpiNet post-market surveillance program will be fully functional by the end of the year. A May public meeting is planned to catalyze the effort.
Details on draft legislation circulating in the House and Senate.