FDA Hammers Columbia Doc's Clinical Trial Oversight

Law360, New York (March 18, 2014, 2:04 PM EDT) -- The U.S. Food and Drug Administration on Tuesday published a stern warning letter accusing a Columbia University Medical Center physician of poor clinical trial oversight that allegedly included excessive delegation of authority and widespread failure to obtain informed consent from patients.

In its letter to Dr. Ralf Zimmermann, the FDA claimed to have uncovered numerous violations during inspections last year that examined two trials involving unspecified medications related to reproductive health.

One alleged shortcoming arose when Zimmermann handed off too many responsibilities to other personnel, with...
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