Ropes & Gray Podcasts

This episode of Ropes & Gray’s podcast series Non-binding Guidance continues our exploration of recent trends and updates on the use of real-world evidence in drug development. Join Ropes & Gray FDA regulatory attorneys, Kellie Combs and Sarah Blankstein, as they discuss four new draft guidance documents released by FDA in 2021 addressing the use of real-world evidence to support FDA decision-making on safety and effectiveness. Tune in to this episode to learn more about FDA’s current approach to real-world evidence, these recent draft guidances, and what we can expect from FDA looking ahead in 2022 and beyond.