Chart: Sentinel Initiative Starts Life With Eight Evaluation Contracts
Executive Summary
FDA's Sentinel Initiative is an attempt to transform its post-marketing safety monitoring system by creating a national electronic system to link data on 100 million patients from multiple existing health care data systems by 2012. Enshrined in the FDA Amendments Act of 2007, Sentinel will allow FDA to actively search automated data holders - like electronic health record systems, administrative and insurance claims databases, and registries - to rapidly evaluate possible safety issues. The initiative is still in its infancy, but at the recent Post-Approval Summit held at Harvard Medical School in Boston, Melissa Robb, Senior Program Manager at FDA's Office of Critical Path Programs, outlined eight contracts the agency has in place; so far, four contracted reports have been released (see preceding story). Below is a summary of Sentinel's contracts.
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