Court of Appeals for the D.C. Circuit October 22, 2018, Civil Action No. 17-2198 (JEB) (Ctr. for Responsible Sci. v. Gottlieb)

JAMES E. BOASBERG, United States District Judge

Before a new pharmaceutical drug can come to market, testing must prove it to be both safe and effective. Plaintiff Center for Responsible Science believes that the Food and Drug Administration's informed-consent regulation governing these initial human tests does not sufficiently warn participants of the dangers they face.