Citeline Podcasts

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Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

  1. 3D AGO

    Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts

    Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12). #pharma #business More On These Topics From The Pink Sheet Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/ US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/ US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/ US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/

    34 min
  2. 4D AGO

    Forum chief Gwyn Tudor puts the case for medtech development in Wales

    BioWales Podcast: Getting Medtech Right In A Small Country Maximizing The Tailwind From BioWales 2026 Gwyn Tudor, head of the MediWales forum, lays out the challenges, opportunities and funding on offer for healthtech founders who make Wales part of their strategic plan. For healthtech companies looking to move from start-up to manufacturing and scale-up, Wales can be an attractive location, with its quality manufacturing facilities, expertise and often lower costs than in other parts of the UK. That was one of the messages from Gwyn Tudor, chief executive of the Cardiff-based MediWales forum, “the independent life sciences network for Wales”, as he opened the BioWales in London 2026 conference and exhibition. Interviewed by In Vivo for his take on the current commercial and innovation climate for healthtech companies considering operations in Wales, he said that adoption of new technologies by NHS Wales can be just as much of a challenge as in England. He added that NHS Wales is an accessible partner and there is “always a conversation to be had in Wales about new technology and innovation.” Companies can access potential partners, supply chains and peer support through MediWales and events like MediWales Connects. Tudor said: “Building relationships to reduce friction and move projects faster by helping people work together in a less transactional, more relationship-based approach is a clear characteristic of Wales.” Its life sciences ecosystem of 288 companies, 12,000 employees and annual sales output of £2.5bn sales value from medtech, diagnostics, wound healing, regenerative medicine and cell therapy is relatively small on an international scale. But it punches above its weight in medtech and diagnostics, Tudor told delegates at the bustling BioWales event, explaining in this In Vivo podcast his goal of “keeping all life sciences stakeholders in the room to come up with solutions.” That includes the healthcare provider, he said.

    8 min
  3. MAY 1

    Drug Fix: The New Acting US FDA Biologics Center Director, SCOTUS Eyes Generic Drug Policy

    Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Generics Bulletin Executive Editor Dave Wallace discuss US Food and Drug Administration Commissioner Martin Makary’s appointment of Katherine Szarama as acting Center for Biologics Evaluation and Research director and the updated timeline for find a permanent director (:33), as well as and Makary’s approach compared to the recent Center for Drug Evaluation and Research leadership change (4:39). They also consider the impact of the US Supreme Court’s review of the generic drug skinny label policy (10:54). #pharma #business More On These Topics From The Pink Sheet Alternate Leadership Strategy: Deputy Director Szarama Is Acting US FDA Biologics Center Chief: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/alternate-leadership-strategy-deputy-director-szarama-is-acting-us-fda-biologics-center-chief-P6ZJLJY7YBDUXCG6DMWNYNIHUI/ US FDA’s Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fdas-makary-expects-to-name-permanent-cber-director-within-weeks-as-prasad-departs-37ZOLQT6FNDARGPMZOE2EI2DPE/ Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?: ⁠https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/skinny-label-at-scotus-could-generics-maintain-carve-out-authority-no-matter-the-decision-54CTMA7XSBGIFF7WOYPGA26PGM/

    26 min
4.2
out of 5
30 Ratings

About

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

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