FDA Accelerated Approvals and COI Phenomenons With Bishal Gyawali

Chadi welcomes back Bishal Gyawali (@oncology_bg), MD, PhD, Queen’s University Cancer Research Institute (Canada), to the show to discuss the history of the FDA’s accelerated approval regulatory pathway, how it is sometimes abused, how low-level surrogate endpoints are being used for approval, what happens (and what should happen) when confirmatory trials do not confirm clinical benefit for drugs approved through this pathway, how conflicts of interest may impact some regulatory decisions, and so much more. Dr. Gyawali raises some thought-provoking questions and critical points in this deep, nuanced discussion. Check out Chadi’s website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on Youtube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA