FDA Hit With Suit Over Reporting Leeway For Clinical Trials

Law360 (December 10, 2018, 8:01 PM EST) -- A New York University faculty member and a former U.S. Food and Drug Administration official have hit the agency with a suit challenging a rule they said relaxed the reporting requirements for researchers doing certain clinical trials.

Journalism professor Charles Seife and Peter Lurie, ex-associate commissioner for public health strategy and analysis at the FDA, filed the complaint in New York federal court Friday against the agency, the U.S. Department of Health and Human Services, and the National Institutes of Health. The complaint said that the final rule creates certain requirements for registering clinical trials and reporting their results, but that...

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