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NEW YORK (GenomeWeb) – US Food and Drug Administration Commissioner Scott Gottlieb aims to position the FDA as a facilitator of laboratory test innovation, as agencies and legislators craft a long-term solution for regulation of laboratory-developed tests, he said during a presentation at the American Clinical Laboratory Association conference in Washington DC on Tuesday.

"We have a unique opportunity to set reform and innovate as we consider the right mold for the FDA with respect to laboratory-developed tests," Gottlieb said.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.