Ctr. for Responsible Sci. v. Gottlieb
Court of Appeals for the D.C. Circuit
1Opinion of the Court
JAMES E. BOASBERG, United States District Judge
Plaintiffs-three individuals and the Center for Responsible Science-believe that everyone who participates in a clinical-drug trial should be aware of differences in the data between preclinical animal testing and clinical human-subject experimentation. To that end, in May 2014, they submitted a Citizen Petition to the Commissioner of the Food and Drug Administration requesting that three specific warnings be added to the standard informed-consent materials. When the FDA denied the Petition, Plaintiffs brought this one-count Administrative *7Procedu…
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