Ni Aye Khin

Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA


Dr. Ni Khin is currently Division Director in Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA. In this position, she provides regulatory scientific oversight for CDER assigned bioresearch monitoring activities. She participates in onsite inspections of sponsors/CRO and clinical investigators both in the US and abroad. She also leads OSI’s international collaboration with global regulatory counterparts in good clinical practice. Prior to joining OSI, she was a Lead Medical Officer in Division of Psychiatry Products, Office of New Drugs, where she oversaw reviews of IND protocols and NDAs. She is board-certified in Psychiatry by the American Board of Psychiatry and Neurology.