Lawmakers, AMA, Advocates Press FDA For Sex-Specific Data, Labeling

July 21, 2014 at 1:15 PM
FDA is defending its policies for sex-specific clinical trial data as lawmakers, women's health advocates and the American Medical Association ramp up pressure on the agency and sponsors to collect and communicate the information to consumers and physicians. FDA drug center Director Janet Woodcock recently told lawmakers that the agency is on track to meet a deadline this month for a FDA Safety and Innovation Act-mandated action plan on clinical trial data for women and demographic subgroups and rebuffed arguments...


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