FDA Real World Evidence Program- Opportunities and Challenges

M. Khair ElZarrad, Ph.D, MPH, deputy director of the Office of Medical Policy at FDA's Center for Drug Evaluation and Research, delivered a plenary address at the OHRP RCF in Overland Park, Kansas in April 2019. Dr. ElZarrad described the framework of FDA's Real-World Evidence (RWE) Program, and provided an overview of the opportunities and challenges associated with innovative technologies and novel study designs. RCF host KU Medical Center of the University of Kansas posted this video for public distribution.