Episode Details

Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and implications for generic drugmakers, overlooked and emerging FDA issues for pharma and biotech companies, and much more.

In our headlines segment, Wayne highlights these major developments: 

FDA announces broad recruitment effort to expand range of people on advisory committees 

Pharma: FDA launches expedited Investigational New Drug (IND) pilot program 

Devices: AI and robotic surgery among FDA's top areas of focus in FY27 guidance priorities 

Food: PepsiCo recalls over 122,000 cases of Gatorade after bottles were found to contain undisclosed Yellow No. 5 and/or Yellow No. 6