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BIMO Tackles Clinical Trial Lapses With Training, Guidance, PMA Review Holds

This article was originally published in The Silver Sheet

Executive Summary

FDA’s DEVICE BIORESEARCH MONITORING PROGRAM is reinvigorating efforts to obtain compliance from clinical investigators and company sponsors charged with overseeing their conduct, following an alarming rise in violation rates. An online training course for clinical investigators is being prepared, a monitoring guidance for sponsors of clinical trials will be rewritten, and an inspection project to assess overall investigator compliance is underway. Meanwhile, FDA has initiated disqualification proceedings against three clinical investigators, and has halted premarket review of applications from three firms believed to have submitted unreliable data

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