Dr. Thomas Laughren, currently a consultant in psychiatric drug development, is retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Prior to joining the FDA in September 1983, he 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. He is board certified in general psychiatry. As Division Director for the Division of Psychiatry Products, he oversaw the review of all psychiatric drug development activities conducted under Investigation New Drug (IND) and New Drug Applications (NDA) 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.