Mar 182011

The FDA plans to issue a guidance this year to help sponsors address gender disparity in clinical trial data submitted to the agency. Over the last several years, the Center for Devices and Radiological Health (CDRH) has hosted a series of public workshops to gain input on achieving appropriate gender representation and conducting analysis for gender differences, given the challenges unique to device trials. Input from these meetings will be tied into the forthcoming guidance, the FDA said March 2: Clinical Trials Advisor

(Reprint: FDANEWS vol. 8, No. 55)