Legal Opinion
Ctr. for Responsible Sci. v. Gottlieb
Court of Appeals for the D.C. Circuit
Decided October 22, 2018No. Civil Action No. 17-2198 (JEB)PublishedCited by 6 opinions
1Opinion of the Court
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. CRS thus proposed that the FDA amend its regulation to add three additional disclosures, but the Agency demurred. Plaintiff then turned to the courts. It filed a one-count Complaint under the Administrative Procedure Act…
2Cases cited30 opinions
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3Cited by6 opinions
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