FDA Holding Off on Finalizing Regulatory Guidance for Lab-Developed Tests

Nov 18, 2016

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This article has been updated with additional comment from the FDA regarding a Senate committee hearing in September, and a statement from the Personalized Medicine Coalition.

NEW YORK (GenomeWeb) – Amid post-election uncertainty, the US Food and Drug Administration has decided to delay finalizing its draft guidance on regulating lab-developed tests, GenomeWeb has learned.

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