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 15 episodes on record and a Required Pod Score of 80.

Unknown Host hosts Pink Sheet Podcasts, a business show with 15 episodes published.

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  Pink Sheet Podcasts

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

  Sep 25, 202630 min

  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 (16:06) and more practical issues like advisory committee meetings (21:23). They also look at the remaining hurdles for Overton’s bid to take control of the agency (24:40). More On These Topics From The Pink Sheet Overton Calls MMR Vaccine ‘Not Lethal,’ Defends Trump’s Claim As Outreach To Vaccine Skeptics: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/overton-calls-mmr-vaccine-not-lethal-defends-trumps-claim-as-outreach-to-vaccine-skeptics-TO3WNT3NUZGJ5IDRRUBDHF5CIA/ US FDA Commissioner Nominee Overton Says Adcomms ‘Critical,’ Hedges On Mifepristone Safety: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-nominee-overton-says-panels-are-critical-hedges-on-mifepristone-safety-RGSODPP5IRHLDA7A26TGOZ7LRI/ Former FDA Commissioners’ Backing May Help Overton Amid Stakeholder Opposition: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/former-fda-commissioners-backing-may-help-overton-amid-stakeholder-opposition-66MIFWT47ZDKDLYEFSBHMUEOEE/

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  Pink Sheet Podcasts

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

  Sep 11, 202636 min

  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 commissioner could have on the positions (3:20). They also discuss the FDA’s limited advisory committee schedule and the potential reasons recent senior leadership changes have not spurred more meetings (18:22). More On These Topics From The Pink Sheet US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-davis-mikhail-gain-permanent-cder-cber-director-positions-47N2SXKPHRB6BCBFLJGUF3Y2NA/ US FDA Advisory Committee Meetings Remain Rare Despite Leadership Changes: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-meetings-remain-rare-despite-leadership-changes-LD3DFLJYQFDVFCERZXRBVECY3M/

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  Pink Sheet Podcasts

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

  Sep 4, 202638 min

  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). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59). More On These Topics From The Pink Sheet US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/ US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-scraps-program-that-paid-bonuses-for-completing-speedy-drug-reviews-JF5MQA73GJHDZADHXQSTB6JA2A/ US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/

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  Pink Sheet Podcasts

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

  Aug 28, 202630 min

  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 MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/mfn-deal-impact-unclear-as-white-house-ready-to-announce-agreements-with-mid-size-pharmas-ECRFYU4TOVBSPG63U26CWI5FIM/ HHS Builds A Legal Firewall Around Its Next Vaccine Moves With RFI On Federal Categories: https://insights.citeline.com/pink-sheet/vaccines/hhs-builds-a-legal-firewall-around-its-next-vaccine-moves-with-rfi-on-federal-categories-5HILL2G52BE3PI5BJTJ4UZ76RI/

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  Pink Sheet Podcasts

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

  Aug 24, 202630 min

  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-leadership/us-fda/fda-commissioner-nominee-has-the-white-houses-trust-winning-over-career-staff-is-another-matter-IIZWK46CFVHMBIZF5XM7L4PQ6U/ Trump To Nominate White House Advisor Overton As FDA Commissioner: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/outgoing-georgia-congressman-buddy-carter-eyed-for-fda-commissioner-RHIYQUYTIVGRTFEXYCHCWPG54Y/

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