Gottlieb: FDA Seeks Flexible Next Generation Sequencing Test Development, Reduced Reg Burden

FDA Commissioner Scott Gottlieb on Tuesday (March 6) spotlighted the agency’s efforts to reform the premarket review process for diagnostic tests, and he previewed next steps, which include qualifying third-party reviewers and third-party databases to help with reviews and approvals, reducing regulatory burden on next generation sequencing (NGS) developers, and providing flexibility in clinical analysis and validation. Gottlieb, speaking to an audience at the American Clinical Laboratory Association’s Annual Meeting on Tuesday, said that while he still believes comprehensive legislation...