FDA, Defense partnership announced

NEWS IN BRIEF — Posted Aug. 27, 2007

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The Food and Drug Administration and Dept. of Defense announced Aug. 2 a new partnership designed to share data and expertise related to review and use of FDA-regulated drugs, biologics and medical devices. Among Defense programs included will be TRICARE, which administers the health plan for 9.1 million uniformed services members, retirees and their families.

The FDA will use general patient data, including prescriptions, lab results and patient weight, to identify trends as well as potential benefits and concerns associated with specific medical products.

The partnership, which will operate under a memorandum of understanding, will become a part of the FDA's Sentinel Network. This sentinel system, which was unveiled in January, is intended to explore linking private- and public-sector information to create a virtual, integrated electronic network. Its long-term plans call for a seamless national electronic information network that will include a range of data, from new medical product information and patient care records to adverse event reports and clinical trial data.

Later this year, the agencies will establish procedures and safeguards necessary to implement the memorandum of understanding.

Note: This item originally appeared at

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