FDA Funds Quality Management Research Project

FDA has awarded $1.7 million to five universities to fund a two-year, wide-ranging research project intended to help the agency better understand how to employ its quality management resources when inspecting drug company manufacturing operations. Schools participating the project are Indiana University, Ohio State University, University of Illinois, University of Wisconsin, and Long Island University.

The project has two aspects. Initially, efforts will go toward developing a statistical model that will provide insights into the effectiveness of FDA efforts. Researchers say they will draw upon data from public sources as well as FDA-provided information to predict which inspection activities lead to higher drug product quality.

The second project will be composed of behavioral experiments to develop a better understanding of the trade-offs between collaborative or adversarial approaches, and the conditions under which such approaches are more effective.