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FDA Turns to Electronic "Sentinel" to Flag Prescription Drug Safety Problems
Bridget M. Kuehn
JAMA. 2008;300(2):156-157.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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In response to criticism of its existing systems for monitoring the safety of drugs and medical devices, the US Food and Drug Administration (FDA) is launching a new electronic system for identifying safety problems once a drug is on the market.
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Researchers will have access to data from Medicare databases as part of a new Food and Drug Administration drug safety program. (Photo credit: Konstantin Sutygain/iStockphoto.com)
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The Sentinel Initiative was officially launched by the agency in May, though some pilot studies were already under way (Kuehn BM. JAMA. 2006;296[12]:1457). Although the program initially will probe claims from Medicare's Part D prescription drug program cross referenced with medical and hospitalization Medicare claims, the agency said it is developing public-private partnerships that will eventually allow it to search health care databases from insurers, hospitals, and other entities that collect such information.
Data derived from the Sentinel . . . [Full Text of this Article] SPOTTY REPORTING
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