The scientific discipline of real world data generation is evolving. PDUFA VI and 21st Century Cures Act included provisions to evaluate the use of real world evidence in the drug review process. Currently, experience and precedent for use of RWD as evidence in regulatory decision making is limited, and there is a need for a clear path to ensure the predictable use of RWD as evidence to support key regulatory decisions. This session will explore ways in which FDA and industry continue to advance the use of RWE to accelerate the drug development process.

Session ID: 0315184