FDA Should Facilitate Lab Test Innovation, Craft Long-Term Regulatory Overhaul, Gottlieb Says at ACLA

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.