FDA Draft LDT Guidance Slated for Release in 60 Days; Industry Readying Recommendations, Objections | GenomeWeb

Originally published Aug. 5.

NEW YORK (GenomeWeb) – In notifying the US Congress last week of its plan to release a draft guidance on regulation of laboratory-developed tests, the US Food and Drug Administration has essentially given industry players and legislators opposed to such government oversight more time to formulate their battle plan.

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