Case studies of FDA recently approved product applications using real-world evidence: an interview with Jie Li, Gerald Dal Pan and John Concato, FDA

16 Aug 2023

Written by Gerald Dal Pan (FDA), Jie Li (FDA), John Concato (FDA)

Interviews Medical devices, pharmaceuticals and vaccines Real-world evidence Regulation

FDA case studies using real-world evidence

Since the passing of the 21st Century Cures Act in 2016, the FDA has made significant progress towards the use of real-world evidence (RWE) to support regulatory decision making. In this interview, Jie Li, Gerald Dal Pan and John Concato from the FDA discuss the learnings from several case studies where product approvals have been supported with RWE. This research is being presented as a poster called ‘Case studies of FDA recently approved product applications using real-world evidence - What are the attributes of studies that support effectiveness determinations?’ at the forthcoming International Conference on Pharmacoepidemiology & Therapeutic Risk Management...