The FDA Sentinel Initiative: Holy Grail of Safety Signal Data

Posted by on October 1, 2012

Back in 2008, FDA launched the Sentinel Initiative, the goal of which is to establish “… a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices once they reach the market.” This fascinating initiative is designed to serve as a proactive alternative to retrospective “one-off” evaluations
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Prioritizing FDA Adverse Event Reporting

Posted by on March 22, 2012

FDA has recently issued a series of guidance documents related to prioritizing and classifying significant post market drug safety issues. One document, intended for regulatory professionals, describes the process that FDA will use to categorize adverse drug events as priority, standard, or emergency. This prioritization structure stems from FDA’s tracking of potential signals of a
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Should you stop taking your vitamins?

Posted by on December 15, 2011

Two vitamin-related studies have recently made a splash in the media. Both studies reported that taking extra doses of vitamins can do more harm than good.
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Are you making the GRADE?

Posted by on December 5, 2011

Making proper judgments about the quality of scientific evidence and recommendations can be complex for scientists, let alone lawyers litigating drug and medical device litigation. Nevertheless, if you are an attorney wading through published scientific papers, it is your job to effectively grapple with these complexities. With this in mind, the GRADE working group developed the Grade
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Dietary Supplements: Are they still good for consumers?

Posted by on December 5, 2010

What’s happening?
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