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Home » Business, Policy & Funding » Business News » Industry to Seek Details from FDA on Risk Classification, Implementation of LDT Regulatory Framework

Industry to Seek Details from FDA on Risk Classification, Implementation of LDT Regulatory Framework

Aug 06, 2014
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Turna Ray
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NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear and confront old issues around the agency's authority over labs.

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