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Don't Finalize LDT Guidance, House Appropriators Tell FDA

FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.

House appropriators directed FDA to halt their work on finalizing a laboratory-developed test guidance and instead work with Congress on a new pathway to regulate LDTs in a FY 2017 funding bill

passed by the full Appropriations

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