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61509 1497862462HCLSReviewTaiwanJune2017.pdf
Energy Boardroom

Companion Diagnostics and the Role of the FDA

21.04.2014 / Thomson Reuters Blog

FDA published a draft guidance for IVD companion diagnostics in July 2011, but has yet to deliver a final guidance, a lag time approaching three years.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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