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FDA’s Sentinel initiative

This article was originally published in The Tan Sheet

Executive Summary

FDA will tap Medicare Part D's large-scale claims database for the pilot phase of its Sentinel post-market drug safety surveillance initiative, Health and Human Services Secretary Mike Leavitt announced May 22. The Sentinel initiative aims to create a national electronic system for monitoring the safety of drugs and devices, and will also incorporate elements of FDA's Adverse Event Reporting system (1"The Tan Sheet" Feb. 20, 2006, p. 5). A 2white paper also released May 22 does not indicate when a full-scale network of participants will be ready, but notes the agency will start using Part D data as soon as practicable to launch the project...

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