Scott Gottlieb envisions a day when only 10% of new diagnostics will have to undergo pre-market review by US FDA to reach market. The FDA commissioner spoke of his vision to an audience of patient groups, IVD kit manufacturers, and laboratory leaders Sept. 13.
Gottlieb joined Timothy Stenzel, who recently moved from industry to head FDA's Office of In Vitro Diagnostics and Radiological Health, at a meeting organized by the Friends of Cancer Research...