Industry / United States
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Sentinel System To Redefine Post-Marketing Surveillance
May 2008 | Industry NewsSorry, you must be a subscriber to view this article in full. If you are a subscriber please login.
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The US FDA has outlined an ambitious new initiative to monitor the safety of pharmaceuticals and medical devices. The FDA plans to create a national, integrated, electronic system, known as the Sentinel System, to track product safety. This is a major shift in post-marketing surveillance in the US and has been driven in part by the requirements of Food and Drug Administration Amendments Act, 2007 (FDAAA). The move comes at a time when there is growing patient concern about the speed at which potential medicine safety issues are