written on 21.04.2014
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Companion Diagnostics and the Role of the FDA

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FDA published a draft guidance for IVD companion diagnostics in July 2011, but has yet to deliver a final guidance, a lag time approaching three years. That three-year lag underscores the complicated nature of efforts to regulate companion diagnostics, a task not eased by the rapidly evolving technological landscape. One of FDA’s remarks in the […]

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