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 .

Pink Sheet Podcasts is a business podcast hosted by Unknown Host, with 0 episodes on record and a Required Pod Score of 80. PitchCentric scores this show on Booking Probability, Listen Score, and live audience signals refreshed every 24 hours.

Unknown Host hosts Pink Sheet Podcasts, a business show with 0 episodes published.

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  Pink Sheet Podcasts

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

  Aug 14, 202629 min

  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 FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/ Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/ Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/

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  Pink Sheet Podcasts

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

  Aug 7, 202624 min

  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 research institutions (16:20) and the resources the pilot will require (20:29). More On These Topics From The Pink Sheet Oncology Overlap, Nationalism Cast Doubts On Potential AstraZeneca/BMS Merger: https://insights.citeline.com/pink-sheet/policy-regulation/oncology-overlap-nationalism-cast-doubts-on-potential-astrazenecabms-merger-NL65J53QYNF57GBW53AZGSYD54/ Merged AstraZeneca, BMS Would Have Deep Solid Tumor And Blood Cancer Portfolio: https://insights.citeline.com/pink-sheet/r-and-d/merged-astrazeneca-bms-would-have-deep-solid-tumor-and-blood-cancer-portfolio-IF4Z7IRHEFDIRDUAZTZP2PHEDM/ US FDA’s IND Reform Pilot Could Use External Partners To Speed Trial Set-Up: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fdas-ind-reform-pilot-could-use-external-partners-to-speed-trial-set-up-7QU7Y7US4FCJRLRWZWV4CLCQBA/

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  Pink Sheet Podcasts

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

  Jul 17, 202631 min

  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 hearing for President Trump’s US Centers for Disease Control and Prevention and Health and Human Services Assistant Secretary for Preparedness and Response nominees (15:12). More On These Topics From The Pink Sheet US FDA Says Two Makary, Prasad Journal Articles And NPV FAQ Were Not Policy Or Guidance: https://insights.citeline.com/pink-sheet/legislation/us-fda-says-two-makary-prasad-journal-articles-and-npv-faq-were-not-policy-or-guidance-6MCDQTKVXFG7TJ7IWOT6YMW4CA/ US CDC, ASPR Nominees’ Confirmations In Question After Contentious Senate Hearing: https://insights.citeline.com/pink-sheet/agency-leadership/us-cdc-aspr-nominees-confirmations-in-question-after-contentious-senate-hearing-3TX2W6HSXRACJELUX2CYY6ICVY/

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  Pink Sheet Podcasts

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

  Jul 10, 202635 min

  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 On These Topics From The Pink Sheet US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fda-to-clarify-expand-significant-discretion-to-publish-crls-NYZ2YV2DCFD6HDJ3XTLRZPXSRY/ US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-moves-to-eliminate-adequate-provision-for-dtc-broadcast-ads-5Y32BOH25JEXVLE4ES2JMFHYLQ/ HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/hhs-considering-us-fda-reorganization-with-medical-products-chief-overseeing-centers-7DSI2OHYUBHXTO73OBBDJW2QQA/

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  Pink Sheet Podcasts

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

  Jun 26, 202627 min

  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 agency’s planned pilot program to streamline IND clearances, including questions about the program’s feasibility. (14:08). More On These Topics From The Pink Sheet US FDA Rewrites Effectiveness Playbook, Positions Single-Pivotal-Trial Pathway As New Normal: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-rewrites-effectiveness-playbook-positions-single-pivotal-trial-pathway-as-new-normal-XUVWF3SKQNANDMY4IW5SXTJZYE/ US FDA IND Reform Pilot Would Let ‘Qualified’ Outside Institutions Give Advice To Speed Approval: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-ind-reform-pilot-would-let-qualified-outside-institutions-give-advice-to-speed-approval-RIPFHRJUERCULKXWCQMXW3PX3M/

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