Gottlieb: LDT 'Collaborative Community' Idea May Offer Cancer Research Model

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13). In August, FDA floated what it pegged as technical assistance to pending legislation that would cement the agency’s authority to regulate high-risk clinical laboratory diagnostics, including laboratory-developed tests and in-vitro diagnostics. FDA,...