FDA: Rethink how diagnostics are regulated
Feb. 6, 2018—U.S. Food and Drug Administration commissioner Scott Gottlieb, MD, said we need to think differently about how we regulate diagnostics. “It’s been a little bit more challenging to define a pathway on how to get regulatory approval for the diagnostic at the same time you get regulatory approval for the drug, in part because a lot of these diagnostic tests have been promulgated as laboratory-developed tests, so they haven’t been brought through a traditional regulatory process,” Dr. Gottlieb