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Sentinel governance report

This article was originally published in The Gray Sheet

Executive Summary

FDA posts 1report May 21 by the eHealth Initiative Foundation on "Developing a Governance and Operations Structure for the Sentinel Initiative," which outlines the scope of the collaborative efforts to support FDA's Sentinel post-market safety surveillance system and recommends governance options and a phased approach to launching the effort. The report resulted from one of eight contracts awarded by the agency last year to support the Sentinel undertaking (2"The Gray Sheet" May 18, 2009, p. 14)

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Chart: Sentinel Initiative Starts Life With Eight Evaluation Contracts





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