U.S. Food and Drug Administration Commissioner Scott Gottlieb recently discussed the agency’s efforts to reform premarket review for diagnostic tests.
Gottlieb made the comments during Tuesday’s annual American Clinical Laboratory Association’s meeting.
During the meeting, according to an Inside Health Policy report, the commissioner looked at some of the next steps toward achieving reform goals, which include third-party reviewers and databases to assist with reviews and approvals, as well as reducing the red tape around next generation sequencing developers.
