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FDA post-market drug surveillance system to tap EHR data

March 1, 2019

Sentinel, which monitors FDA-approved drugs through active surveillance, is being enhanced to capture clinical data to better detect potential new safety problems.

“We’ll be working to link claims data in Sentinel to electronic health records, to improve our ability to conduct active surveillance and use real-world data to improve patient outcomes,” testified FDA Commissioner Scott Gottlieb, MD, on Wednesday during a House appropriations subcommittee hearing on the status of the agency’s operations.

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