Real-World Evidence — Where Are We Now?

Abstract

Interview with Kushal Kadakia on the 21st Century Cures Act, Cures 2.0, and lessons from Covid-19 for medical product development. (11:29)Download Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.