Ni Aye Khin

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

Ni A. Khin, M.D., is Director of Division of Clinical Compliance Evaluation, within Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research, at FDA. In this position, she provides scientific oversight for CDER-assigned bioresearch monitoring (BIMO) activities including compliance programs of clinical investigators, sponsors and contract research organizations. She also leads OSI’s international collaboration with global regulatory counterparts in good clinical practice (GCP) initiatives.

 

Prior to this position, Dr. Khin served as Lead Medical Officer in the Division of Psychiatry Products, Office of New Drugs, where she oversaw the review of clinical protocols submitted under investigational new drug applications (INDs) for all phases of drug development. She also managed clinical reviews of New Drug Applications (NDAs) for all psychiatric indications. Dr. Khin joined the Agency in 2001 as a Clinical Reviewer in the Division of Neuropharmacologic Drug Products. She also served as Medical Officer and Branch Chief of GCP Branch 1, Division of Scientific Investigations. She conducted data-audit inspections of clinical trial sites both in the US and abroad. Prior to coming to FDA, Dr. Khin was a Senior Staff Fellow in the Geriatric Psychiatry Branch at the National Institute of Mental Health.

 

Dr. Khin received her medical degree from the Institute of Medicine I, Rangoon, Burma (Myanmar). She completed residency training in Psychiatry at the State University of New York, Buffalo. She is board-certified in Psychiatry by the American Board of Psychiatry and Neurology. She also received a Master of Science Degree in Microbiology from Arizona State University. Her research interest includes trial design and methodology to improve detection of efficacy signals as well as regulatory and scientific issues regarding use of non-US data from multi-regional clinical trials in support of NDAs.