Drug study participants and a public health interest group couldn’t show their injuries entitled them to sue the FDA over its informed consent procedures for clinical trials.
The plaintiffs sued the Food and Drug Administration claiming it was abdicating its duty to obtain informed consent from human participants in drug trials by failing to warn them about the differences between animal and human testing. Informed consent or lack thereof is often a key element in suits involving medical research.
But Judge James E. Boasberg of the U.S. District Court for the District of Columbia said the none of the ...
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