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Article: FDA system to search for adverse events.(Practice Trends)(Food and Drug Administration)
- Article from:
- Internal Medicine News
- Article date:
- July 15, 2008
- Author:
CopyrightCOPYRIGHT 2008 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The Food and Drug Administration has developed a new national electronic surveillance system that will allow it to search and analyze claims data and other clinical databases for possible postmarket adverse events for drugs and medical devices.
The Sentinel Initiative is designed to bring safety concerns from approved drugs and other medical products to the FDA's attention faster than the traditional MedWatch adverse event reporting system alone.
"We are moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market," Health and Human Services Secretary ...