FDA Crashing 5-hour Energy Dietary Supplement?

Posted by on November 16, 2012

This week the New York Times reported they learned in an interview with an FDA official that FDA has been investigating the “possible” involvement of the dietary supplement 5-hour ENERGY in the deaths of 13 individuals over the last four years.
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Meningitis Product Liability Litigation: Definition of Injection?

Posted by on November 13, 2012

The CDC reports that the multi-state meningitis outbreak linked to tainted steroid injections have left over 30 dead and over 400 infected. Across the country, litigation is taking shape against not only New England Compounding Center, the drug-mixing pharmacy linked to the contaminated lots, but also against physicians and clinics.  However, the success of these latter suits
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What do scientific organizations consider as valid evidence?

Posted by on October 19, 2012

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 report highlights the methods and criteria used by various reputable scientific organizations (e.g., International Agency for Research on Cancer and the American Institute for Cancer Research) and how these organizations
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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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