IU to Help FDA Understand Drug Quality Metrics
BLOOMINGTON, Ind. – Indiana University is one of the five institutions to share a nearly $2 million grant from the U.S. Food and Drug Administration to study drug companies’ manufacturing operations.
IU is administering the federal contract.
The FDA wants to better understand how to employ its quality management resources when inspecting drug companies.
“We intend to help the FDA understand not just what should be done to improve drug quality but how, and under what conditions, it should be done,” said George Ball, assistant professor of operations and decision technologies at the IU Kelley School of Business. “Our objective will be to examine which FDA quality management activities are most effective, given a set of conditions, at stimulating firm attention to quality risk such that learning and subsequent product quality improvement occurs."
IU says adverse drug events cause nearly 1 million emergency room visits each year.
"These insights will help the FDA more effectively and efficiently ensure the safety, quality, and efficacy of the global supply of drugs consumed by all Americans," said Ball.
The other universities include the University of Illinois, University of Wisconsin, The Ohio State University and Long Island University.