Pink Sheet Podcasts

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Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), in

Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of nationalism on the regulatory process, which entered the fray once again when news of a potent

Drug Fix: US FDA Undoes Podium Policy, Lessons From CDC, ASPR Confirmation Hearings

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration clarifying that journal ar

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

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 compl

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

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-t

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

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 enf

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

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 implicatio

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

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 activ

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

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 t