Gerard Olson

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

1/21/2017  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests
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