Dr. Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the FDA. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” the FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently. Most recently, Dr. Woodcock launched the “Safety First” and “Safe Use” initiatives designed to improve drug safety management within and outside FDA, respectively. Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. Prior to joining CDER she oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.