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Medical Devices / Commercial Operations

FDA Hosts NGS Webinars

Aug. 1, 2016

 The FDA will host two webinars to provide details on its guidances on next-generation sequencing technologies.

The draft guidances are part of President Obama’s Precision Medicine Initiative, which aims to take advantage of genomic testing to accelerate the development of new personalized treatments.

The agency released two complementary draft guidances earlier that set a foundation for a flexible regulatory pathway for genomic tests. The pathway streamlines submission and review of data supporting clinical validity of NGS-based in vitro diagnostics. — Tamra Sami

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