CDER Director: Interest in How Patients Feel & Function

October 31, 2017

Many of the US FDA’s drug initiatives over the past decades have been led by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER). In 2000, she introduced the concept of risk management to drug safety. Since 2002, she has led the Pharmaceutical Quality for the 21st Century Initiative, FDA's successful effort to modernize drug manufacturing and its regulation; more recently, Dr. Woodcock launched the "Safety First" and "Safe Use" initiatives designed to improve drug safety management inside and outside FDA. Dr. Woodcock shares her thoughts on real-world evidence, randomized clinical trials, the relationship between the two, and patient-focused drug development, in this Global Forum podcast, as well as drug pricing: "How do we get the cost of drug development to be more reasonable, so that society can afford these interventions when they come out?”