Thomas Laughren, M.D.

Director, Regulatory Affairs, MGH CTNI

FPOIn addition to his position at MGH, Dr. Laughren is currently a consultant in psychiatric drug development in several other settings as well.  He is recently retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA. Prior to coming to FDA in September, 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and also completed residency training in psychiatry at the University of Wisconsin. Dr. Laughren is board certified in general psychiatry.  As Division Director for the Division of Psychiatry Products, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored and co-authored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs, and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory accomplishments.