Why Did You File The Daubert?

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Over the years, Innovative Science Solutions has provided our fair share of scientific support on litigation matters involving Daubert hearings. Specifically, we have worked on cases involving the following types of claims that have been evaluated in the context of Daubert rulings:
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Meningitis Product Liability Litigation: Definition of Injection?

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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?

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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

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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

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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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Dietary Supplements: Are they still good for consumers?

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What’s happening?
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