483
Robert Litman, M.D.FDA 483 - Robert Litman, M.D. - February 20, 2020
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Record Details
An FDA inspection of Robert Litman, M.D. in Gaithersburg, MD, identified a significant deviation from an investigational plan. The clinical investigator failed to consult with the sponsor's medical monitor prior to adjusting a subject's antidepressant treatment dose, as required by the study protocol. This indicates a failure to adhere to established clinical trial procedures for a study involving intranasal esketamine for major depressive disorder.
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ID · adaff111-b12b-492c-8d27-e9b87cb83366