The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals

In this third part of our series in collaboration with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President and CEO of Kodiak Strategic Consultants; and Bethany Hills, Regulatory Partner at White & Case. Together, they discuss expedited FDA drug development and review pathways; accelerated approval and its value to sponsors and investors; surrogate endpoints and their role in accelerated approval; the Food and Drug Omnibus Reform Act and FDA's expanded accelerated approval authorities; FDA's evolving current evidentiary standards for accelerated drug approvals; RWE in accelerated approval strategies; FDA expectations for RWE; limitations and controversies surrounding RWE; legal and compliance considerations for sponsors using RWE; and much more. This episode and the rest of our series do not include the usual Headlines segment. To subscribe or find out more information about our podcast, visit FDAWatch.net (http://www.fdawatch.net/) . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net (mailto:info@fdawatch.net) . Music by Dvir Silver (https://pixabay.com/users/sonican-389...) from Pixabay (https://pixabay.com/music/?utm_source...) .