The Food and Drug Administration is being urged to disqualify a Minnesota hospital and two physicians from running clinical trials after the agency found studies that violated regulations on human research.
In a petition, the Public Citizen advocacy group noted FDA inspectors recently warned Hennepin County Medical Center and two physicians for failing to obtain consent from subjects in trials that tested the safety and effectiveness of the medications for managing agitation. The studies involved antipsychotics and the potent anesthetic ketamine on patients in emergency rooms or prior to their arrival.
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