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Latest episodes
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Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework
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October 9, 2026 · 41 minPink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Senior Reporter Maaisha Osman discuss the drama unfolding at the US Food and Drug Administration related to a Health and Human…
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Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes
October 2, 2026 · 31 minPink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Senior Writer Cathy Kelly discuss the limited impact the US Centers for Medicare and Medicaid Services’ Global Benchmark for Efficient Drug Pricing (GLOBE) model…
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Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing
September 25, 2026 · 30 minPink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs dissect US Food and Drug Administration commissioner nominee Heidi Overton’s answers during her Senate…
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Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone
September 11, 2026 · 36 minPink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the impact of Michael Davis and Karim Mikhail’s promotions to permanent…
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Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes
September 4, 2026 · 38 minPink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US…
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Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves
August 28, 2026 · 30 minPink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential differences between Most Favored Nation drug pricing agreements for small and…
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Drug Fix: What FDA Commissioner Nominee Heidi Overton Will Mean For The Agency
August 24, 2026 · 30 minPink Sheet Editor-in-Chief Nielsen Hobbs, executive editor Derrick Gingery, and senior reporter Maaisha Osman discuss new FDA commissioner nominee Heidi Overton, her prospects for confirmation, and what her pick means for the agency. More…
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Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change
August 14, 2026 · 29 minPink 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), including the revenue…
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Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms
August 7, 2026 · 24 minPink 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 potential…
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Drug Fix: US FDA Undoes Podium Policy, Lessons From CDC, ASPR Confirmation Hearings
July 17, 2026 · 31 minPink 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 articles written by…
About the show
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/. For any podcast feedback or queries, you can now reach us at podcasts@norstella.com.