Tom Laughren, MD

Retired Division Director for the Division of Psychiatry Products

Dr. Laughren retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA in Dec, 2012. 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.

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.

Dr. Laughren is currently the Directory of Regulatory Affairs for Massachusetts General Hospital Clinical Trials Network and Institute (CTNI). The focus of Dr. Laughren’s consulting activities for CTNI is on regulatory and scientific strategies to facilitate psychiatric and neurological drug development.