May 1, 2018 / 12:53 AM / in a year

Nonprofit gets second crack at suit to amend FDA drug-trial consent forms

A California-based nonprofit suffered a setback on Friday in its lawsuit against the U.S. Food and Drug Administration over the warnings given to people who participate in clinical drug trials.

Judge James Boasberg in U.S. District Court for the District of Columbia agreed with the FDA that the Center for Responsible Science (CRS) had failed to show it had standing to sue, but gave the organization 30 days to amend its pleadings. CRS wants the agency to add warnings that animal studies are a poor predictor of a drug’s safety or effectiveness in humans.

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