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FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
Date:1/8/2010

safety efforts," said FDA Commissioner Margaret A. Hamburg, M.D.

The Sentinel System fulfills some requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which include provisions calling for the development of such a system.

The Harvard Pilgrim contract is one of the many activities contributing to building the Sentinel System. The FDA already has awarded 10 small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement. In addition, the FDA has awarded a cooperative agreement with the Brookings Institution to convene meetings and workshops on active medical product surveillance issues. The workshop on the Sentinel Initiative is scheduled for Jan. 11, 2010, in Washington, D.C.

"The FDA has been doing the groundwork for a nationwide Sentinel System," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information."

In addition to public meetings, the FDA has opened a docket for public comment, and developed a listserv for those who want to stay apprised of Sentinel developments.

The FDA's Web Page on the Sentinel Initiative

http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

Media Inquiries: Karen Riley, 301-796-4674,

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
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