Pink Sheet Podcasts

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the implications of potential regulations that would cement the FDA’s presumption that it can release complete response letters (:49) and effectively ban direct-to-consumer advertising (18:45), as well as a potential reorganization to create a senior FDA position in charge of all medica...

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss the potential impact of the US Food and Drug Administration’s new updated guidance describing the one-trial plus confirmatory evidence standard for effectiveness (:47) and the significance of advancing yet another priority of former Commissioner Martin Makary (6:47). They also talk...

Pink Sheet Editor-in-Chief Nielsen Hobbs, Senior Editor Sue Sutter, and Senior Reporter Maaisha Osman discuss the Pentagon's decision to list WuXi Apptec as a “Chinese military company” (0:58), FDA’s latest adverting enforcement letters (13:02), and the agency’s thoughts on the risks and benefits of relying on AI for regulatory activities (21:16). More on these topics from the Pink Sheet: Pentagon...

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs, as well as Generics Bulletin Executive Editor David Wallace, consider the implications of the US Supreme Court decision upholding the skinny labeling system (:37), including how the generic industry will adapt going forward (9:02). They also discuss the stakeholde...

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential impact a mandated nondisclosure agreement could have on US Food and Drug Administration activities and its employees (:34), as well as the changes the agency’s hiring push caused to user fee reauthorization efforts (13:50). More On These Topics From The Pink Sheet Proposed...

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs, as well as special guest Mike McCaughan, founding member of Prevision Policy, discuss the circumstances and mistakes that lead to Martin Makary’s resignation as head of the US Food and Drug Administration (:38), his achievements during his short term (21:56), the age...