Overview of CDER’s Real-World Evidence Demonstration Projects

Aligned with the U.S. 21st Century Cures Act, FDA established a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making. The program is multifaceted and supports activities such as demonstration (research) projects, guidance development, internal Agency processes, external stakeholder engagement, and the Advancing Real-World Evidence initiative. This talk presented an overview of several RWE demonstration projects and described, for select projects, how learnings directly or indirectly serve to support FDA regulatory decision-making in evaluating the effectiveness and safety of medical products.