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Response to FDA’s Gottlieb on Reducing Regulatory Burden

FDA chief’s ideas are positive for labs, but an expert said the details will matter

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible […]

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