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
Cosmetics: PCPC urges U.S. Trade Representative to ensure cosmetics and personal care products are prioritized in proposed U.S.-China Board of Trade
In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.
