Business schools collaborate with FDA on drug manufacturing performance study

The U.S. Food and Drug Administration will collaborate with Assistant Professor Jeffrey T. Macher of the Robert Emmett McDonough School of Business at Georgetown University and Associate Professor Jackson A. Nickerson of the Olin School of Business at Washington University in St. Louis as part of its strategic initiative to modernize the regulation of pharmaceutical manufacturing and product quality. Under the terms of the material transfer agreement with the FDA, Macher and Nickerson will conduct research and analysis to help the FDA identify the factors that predict manufacturing performance to further refine the agency’s risk-based site selection model for inspections as well as its other efforts to target identified risks to pharmaceutical quality and strengthen its pharmaceutical compliance program.