The 21st Century Cures Act calls for the FDA to develop and implement a program to evaluate the potential use of real-world evidence (RWE) for regulatory decisions. Many questions remain regarding recommendations the FDA will make, how industry will react, and what this means for the future of RWE and the HEOR community. This session will be a panel discussion with experts who have been involved in the process and can share insights on the anticipated direction of policy and potential implications for the generation, use, and value of RWE in the coming years. The panel will include representatives from FDA’s Center for Drug Evaluation and Research (CDER), the National Pharmaceutical Council (NPC), and the Amgen Center for Observational Research. An important aim of the session is to involve the audience in the discussion by allowing ample time for questions and answers. This symposium will serve as a valuable extension to the overall ISPOR 2018 theme of Real-World Evidence, Digital Health and the New Landscape for Health Decision Making.