Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

December 6, 2018 – The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data. These tools offer new opportunities to use data collected during the routine care of patients to advance medical care. Leveraging such data – typically called real-world data (RWD) – to improve regulatory decisions is a key strategic priority for the FDA. Today, the FDA is announcing our new 2019 strategic … (leggi tutto)