The Future of Drug Regulation: An Interview With Center for Drug Evaluation & Research Director Janet Woodcock

By Michael McCaughan / Email the Author / The RPM Report July 2011, Vol. 7, No. 7
Feature Articles / Word Count: 5475 / Article # 2011500087

Executive Summary

FDA’s top drug regulator sat down for us for an interview about the agency’s efforts to build a higher quality regulatory system in the US—one that focuses on the “content” of regulatory standards rather than just the process. The discussion touched on the need for new and improved standards in classes like weight loss and rheumatology (albeit for very different reasons); the characteristics that make for good drug reviewers (and their managers); and on the drug center’s responsibility for preserving private sector drug development.