Norstella

Pink Sheet Podcasts

Business EN ↓ 6 episodes

The award-winning Pink Sheet editorial team dispenses "Drug Fix" every Friday for regulatory affairs professionals, drug developers, and anyone serious about staying ahead in biopharma. From US FDA review performance to inspection crackdowns to agency leadership shake-ups, we help you understand the regulatory shifts that move markets. Explore the full archive of Pink Sheet's deeper reporting here at https://insights.citeline.com/pink-sheet/

Author

Norstella

Episodes

Drug Fix: New Complete Response Letter, DTC Ad Regulations And A Potential US FDA Reorg 10.07.2026 35:28

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...

Drug Fix: US FDA’s New Guidance On One-Trial Efficacy Standard And IND Reform Pilot 26.06.2026 26:52

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...

Drug Fix: WuXi vs. the Pentagon, New Advertising Citations, And FDA Explores The Limits Of AI 15.06.2026 34:28

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...

Drug Fix: SCOTUS Rules On Generic Skinny Labels, US FDA’s NPV Faces Uncertain Future 05.06.2026 28:48

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...

Drug Fix: Potential Nondisclosure Agreements For US FDA Staff, Hiring Threatens User Fee Reductions 29.05.2026 22:38

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...

Drug Fix: Post-Mortem On Martin Makary’s Tenure As FDA Commissioner 15.05.2026 40:25

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...