Pink Sheet Podcasts

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.

Episodes

Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

October 30, 2026 • 34 mins

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 unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US...

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Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

October 16, 2026 • 28 mins

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) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will ...

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Drug Fix: US FDA’s Peptide Drama, More Transparency, Ibogaine Clinical Trial Plans

October 9, 2026 • 41 mins

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 Services Department plan to temporarily allow some compounding of unapproved peptides (:52). They also consider the impact of the FDA’s intent to acknowledge individual NDA and BLA filings (...

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Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes

October 2, 2026 • 31 mins

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 after it was finalized with only a handful of participants (:58), as well as several other questions still being asked about it (10:24). They also consider the impact of the Food and Drug Admin...

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Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing

September 25, 2026 • 29 mins

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 confirmation hearing and dominant themes (:58), rate the potential for her confirmation (13:14), as well as consider her responses to particular controversial issues like mifepristone safety ...

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Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

September 11, 2026 • 35 mins

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 directors of the US Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, respectively (1:05), as well as the impact a new...

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Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

September 4, 2026 • 38 mins

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 Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05)....

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Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves

August 28, 2026 • 29 mins

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-size companies and the largest pharmas (1:03), as well as the impact of potential vaccine policy changes on the US public health apparatus (15:10). More On These Topics From The Pink Sheet MF...

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Drug Fix: What FDA Commissioner Nominee Heidi Overton Will Mean For The Agency

August 24, 2026 • 30 mins

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 On The Topic From The Pink Sheet FDA Commissioner Nominee Has The White House’s Trust. Winning Over Career Staff Is Another Matter: https://insights.citeline.com/pink-sheet/agency-leaders...

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Pink Sheet Trailer

August 19, 2026 • 56 secs

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

August 14, 2026 • 28 mins

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 cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV. More On These Topics From The Pink Sheet US F...

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

August 7, 2026 • 24 mins

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-Bristol Myers Squibb merger broke (:58), as well as the US Food and Drug Administration’s IND reform pilot program (11:22), including the potentially influential role of external qualified rese...

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

July 17, 2026 • 31 mins

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 former commissioner Martin Makary and others were not official guidance (:58). They also discuss the questions an FDA commissioner nominee could field from Senators based on the recent confirmation...

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

July 10, 2026 • 35 mins

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 medical products (29:23). More O...

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

June 26, 2026 • 26 mins

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 about the details of the agen...

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

June 15, 2026 • 34 mins

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 Chinese...

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

June 5, 2026 • 28 mins

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 stakeholder comments the US Food and Drug Adm...

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

May 29, 2026 • 22 mins

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 Government Nondisclosure...

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

May 15, 2026 • 40 mins

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 agency’s way forward ...

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Pink Sheet Podcasts

Episodes

.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

.css-r6mb8g{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:1;overflow:hidden;}Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

Drug Fix: US FDA’s Peptide Drama, More Transparency, Ibogaine Clinical Trial Plans

Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes

Drug Fix: Lessons From US FDA Commissioner Nominee Heidi Overton’s Confirmation Hearing

Drug Fix: Increasing US FDA Leadership Stability And Where All The Adcomms Have Gone

Drug Fix: US FDA Commissioner Nominee Heidi Overton’s Resume And COVID-19 Vaccine Trial Changes

Drug Fix: MFN Finds Mid-Size Companies And More Vaccine Policy Moves

Drug Fix: What FDA Commissioner Nominee Heidi Overton Will Mean For The Agency

Pink Sheet Trailer

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

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

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

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

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

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

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

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

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

Popular Podcasts

Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework