Real-world data (RWD) and real-world evidence (RWE) are playing an increasingly important role in health care decisions. The FDA uses RWD and RWE to monitor post-market drug safety and clinical adverse events and to make regulatory decisions. The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice. Medical product developers are using RWD and RWE to support clinical trial designs and observational studies to generate innovative, new treatment approaches. This session will touch upon and discuss these various aspects of uses and FDA guidelines of RWD and RWE.