Episode Details

Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on Operation TrialBlazer; what's been happening lately with CBER and CDER; the latest in rare diseases and orphan drugs; developments in cell and gene therapy; the Plausible Mechanism Framework; the situation with China and global drug development; and much more. 

In our headlines segment, Wayne highlights these major developments: 

Acting FDA Commissioner Kyle Diamantas releases new strategic framework built around four public health priorities 

Pharma: FDA makes 14 CRLs available, rejecting drug applications, despite previously pausing real-time CRL transparency initiative

Devices: FDA clears Software as a Medical Device with patient-facing LLM

Food: FDA delays publication of proposed rule to eliminate the GRAS pathway