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<title>The Holy Grail of Safety Signaling for Drugs, Devices, and other Regulated Products: FDA’s Sentinel Initiative</title>
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<dc:creator>Amos Sanchez</dc:creator>
<category><![CDATA[Litigation Hot Topics]]></category>
<description>Back in 2008, FDA launched the Sentinel Initiative, the goal of which is to establish “… a national electronic system that will trans</description>
<pubDate>Thu, 15 Mar 2012 00:21:43 -0400</pubDate>
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<title>What is considered to be valid evidence by reputable scientific organizations?</title>
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<dc:creator>Amos Sanchez</dc:creator>
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<description>The Institute of Medicine (IOM) has taken a critical stance on epidemiologic methods and systems for determining the value of study evidence. This recently published </description>
<pubDate>Fri, 20 Jan 2012 16:09:26 -0500</pubDate>
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<title>FDA Concludes Mortality Increase is Confirmed</title>
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<dc:creator>Amos Sanchez</dc:creator>
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<description>The Food and Drug Administration has completed its safety review and concluded that Multaq increases the risk of death and serious cardiovascular events in persons with permanent atrial fibrillation. The agency issued </description>
<pubDate>Tue, 27 Dec 2011 06:06:40 -0500</pubDate>
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