FDA, in conjunction with the Brookings Institution, will hold a public meeting Sept. 5 to discuss biomarkers, including considerations for early- and late-phase clinical trials, best practices for the codevelopment of in vitro diagnostics and using biomarkers as outcomes measures in clinical trials. The meeting fulfills a goal outlined in the 2012 iteration of the Prescription Drug User Fee Act and comes as these topics are being debated in Congress. FDA is charged with developing the staff capacity to review...