Pink Sheet Podcasts

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Norstella

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.

  1. 3d ago

    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 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 Administration eliminating voting privileges for some advisory committee consumer representatives (15:15), the Health and Human Services Department eliminating some of the FDA’s legal oversight (24:13), and the FDA reopening its search for a cell and gene therapy office director (27:28). More On These Topics From The Pink Sheet Shrinking GLOBE: Medicare Part B Model Seems Increasingly Unlikely To Advance: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/shrinking-globe-medicare-part-b-model-seems-increasingly-unlikely-to-advance-2MFLVAIRWRG7JDEZQP2AQ7VZMY/ Possible GLOBE Participants Down To Four ... And Counting: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/possible-globe-participants-down-to-four-and-counting-4UYTIWXLRNAMXEIR7JNTRCNR3Q/ US FDA Wants Advisory Committee Members, But Not Voting Consumer Reps: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-wants-advisory-committee-members-but-not-voting-consumer-reps-5V4SKVJFB5FJLG2GPKKZJXZVLY/ Reorg Cuts US FDA Chief Counsel Oversight Position At HHS: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/reorg-cuts-us-fda-chief-counsel-oversight-position-at-hhs-5VPOXSOOLRCCVPGWEI2XECL6UE/ US FDA Continues Search For Cell, Gene Therapy Office Director, Lowers Education Requirement: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-continues-search-for-cell-gene-therapy-office-director-lowers-education-requirement-IXJCWUATZBHKZLOTNFSCJBOHYE/

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

  2. Sep 25

    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 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/

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

  3. Sep 11

    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 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/

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

  4. Sep 4

    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 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/

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

  5. Aug 28

    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-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/

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

  6. Aug 24

    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 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/

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

  7. Aug 19

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  8. Aug 14

    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 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/

    Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change
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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 https://insights.citeline.com/pink-sheet/. For any podcast feedback or queries, you can now reach us at podcasts@norstella.com.

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