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

FDA and the Duke-Margolis Center for Health Policy will hold a conference on October 3 in Washington, DC to discuss the role of real-world data and real-world evidence in the regulatory decision-making setting.

On October 3, the FDA and the Duke-Margolis Center for Health Policy will hold a conference,Developing Real-World Data and Evidence to Support Regulatory Decision-Making. The conference is funded through a cooperative agreement between the FDA and Duke-Margolis and will bring together experts to discuss the role of RWD and 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 the FDA’s work in this area, Duke-Margolis Center launched a RWE Collaborative to engage stakeholders on key RWE issues. Sessions at this conference will focus on takeaways from the Collaborative’s efforts to identify and explore issues discussed in the agency’s Framework. White papers produced by the Collaborative will be released during these sessions.  For more information, please visit: Developing Real-World Data and Evidence to Support Regulatory Decision-Making.