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Home » Device Trial Sponsor Cited for Late UADE Reports
Device Trial Sponsor Cited for Late UADE Reports
January 16, 2009
The director of the Johns Hopkins Comprehensive Diabetes Center failed to report unanticipated adverse device effects (UADEs) in a timely manner and used inadequate or outdated informed consent forms in a device study for which he served as both sponsor and investigator, according to an FDA warning letter.