|
|
This session will highlight the Real-World Evidence (RWE) Program at the FDA’s Center for Devices and Radiological Health (CDRH), with a focus on recent RWE examples involving digital health technologies. Through presentations and a panel discussion with CDRH experts, participants will gain practical insight into CDRH's RWE Program and explore how these principles could support evidence generation.
What you will learn:
- The evolution of CDRH’s RWE Program. Participants will be able to describe the milestones and development of the program over time.
- How RWE shapes CDRH regulatory decisions. Participants will explore examples of RWE use in medical device regulatory decisions, including recent examples in digital health, and understand the role real-world data/real-world evidence played in supporting those outcomes.
This event will be offered in a hybrid format, with options to attend in person at the FDA White Oak Campus or virtually via webcast.
This is the first of a three-part RWE series. Future sessions will cover the RWE programs and recent examples in the FDA’s Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
For more information, please contact us at PublicEngagement@fda.hhs.gov.
|
|
|
|
