FDA 483 - Robert Litman, M.D. - February 20, 2020

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.