FDA/Duke Margolis Conference: Developing Real-World Data and Evidence to Support Regulatory Decision-Making

FDA/Duke Margolis Conference: Developing Real-World Data and Evidence to Support Regulatory Decision-Making

The U.S. Food and Drug Administration (FDA) and the Duke-Margolis Center for Health Policy will hold a conference, Developing Real-World Data and Evidence to Support Regulatory Decision-Making, on October 3rd in Washington, D.C. The conference will bring together experts to discuss the role of real world data (RWD) and real world evidence (RWE) in the regulatory decision-making setting.   The conference will examine issues addressed in the Framework for FDA’s Real-World Evidence Program, a 2018 FDA framework that outlines how the agency may use RWD and RWE to make regulatory decisions related to the effectiveness of marketed drug products.   To inform FDA’s work in this area, the Duke-Margolis Center launched a RWE Collaborative to engage stakeholders on important RWE issues. Sessions at this conference will focus on takeaways from the Collaborative’s efforts to identify and explore topics discussed in the agency’s Framework. White papers produced by the Collaborative will be released during these sessions.  To register for the conference, please visit the Developing Real-World Data and Evidence to Support Regulatory Decision-Making workshop webpage.