At Workshop, Labs Tell FDA to Let them Tweak LDTs; Give Their Take on Labeling and Clinical Validity | GenomeWeb

NEW YORK (GenomeWeb) – "The proposal we issued a few months ago, is just that. It's a proposal," Jeff Shuren, director of the US Food and Drug Administration's Center for Devices and Radiological Health, said yesterday at the start of a two-day workshop to discuss the agency's draft guidance on regulation of laboratory-developed tests (LDTs). "We do not claim we have gotten everything right."

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