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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 insights.citeline.com/pink-sheet. For any podcast feedback or queries, you can now reach us at podcasts@norstella.com.
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Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of
Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework
Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53)
Drug Fix: US FDA’s Peptide Drama, More Transparency, Ibogaine Clinical Trial Plans
Pink 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 Serv
Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes
Pink 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 afte
Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing
Pink 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 co
Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone
Pink 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 direct
Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes
Pink 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 Foo
Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves
Pink 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 mid-
Drug Fix: What FDA Commissioner Nominee Heidi Overton Will Mean For The Agency
Pink 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 O
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), including the revenue
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 potential AstraZeneca-Bris
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 articles written by fo
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 complete response letters
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-trial plus confirmato
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 enforcement letters (13
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 implications of the US Supreme
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 activities and its employ
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 the circumstances and
