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FDA’s Temple Sees Sentinel As Important Tool For Confirming And Analyzing Drug Adverse Events

 
• By Cathy Kelly

FDA clinical science expert Robert Temple discusses how the Sentinel project – a drug data monitoring initiative – can support the agency’s postmarket drug safety investigations.

FDA’s Sentinel project could function as an important comparator control for potential drug safety events already being investigated by the agency, FDA’s Robert Temple said during a public workshop on Sentinel sponsored by the Brookings Institution Jan. 18. Sentinel is an initiative the agency is developing to monitor postmarket drug safety events.

Temple, who is deputy center director for clinical science in the Center for Drug Evaluation and Research, characterized Sentinel as...

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