Pink Sheet Podcasts

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/

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

    vor 6 Std.

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

    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/

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

    26. Juni

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

    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/

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

    15. Juni

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

    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 Company Designations Resurface Pharma Supply Chain Concerns ⁠https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/pentagon-chinese-company-designations-resurface-pharma-supply-chain-concerns-BMG2DWJI4NDA3DD3SYHIWXLTZI/⁠ US Legislation Targets US-China Dealmaking Amid Fears Of Ceding Biotech Leadership ⁠https://insights.citeline.com/pink-sheet/legislation/us-legislation-targets-us-china-dealmaking-amid-fears-of-ceding-biotech-leadership-54FLFUBN7RELHO6WC7RN5OINYY/⁠ BIOSECURE Legal Lifeline Available For Pharma Companies Using WuXi AppTec … For Now ⁠https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/biosecure-legal-lifeline-available-for-pharma-companies-using-wuxi-apptec-for-now-KAD42FTHIJAT3AWS6OJMJHFM4M/⁠ Pentagon Cleared WuXi AppTec Once. Now It Is Being Sued for Changing Its Mind. ⁠https://insights.citeline.com/pink-sheet/compliance/manufacturing/pentagon-cleared-wuxi-apptec-once-now-it-is-being-sued-for-changing-its-mind-XVGIQA3LIFEBZAG6AS6EMENHF4/⁠ Recent US FDA Ad/Promo Untitled Letters Citing More Email, Internet Issues, Less DTC TV Spots ⁠https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/recent-us-fda-adpromo-untitled-letters-citing-more-email-internet-issues-less-dtc-tv-spots-X2QUB5LZBRCRLNPGOJZJQMEIWU/⁠ Unapproved Uses Safe Harbor Codified In Revised US FDA Payor Communications Guidance ⁠https://insights.citeline.com/pink-sheet/market-access/government-payers/unapproved-uses-safe-harbor-codified-in-revised-us-fda-payor-communications-guidance-GFHTVUWW7NBH3P2MT6GZL5JLJ4/⁠ US FDA Says AI Played Supporting, Summarizing Role In Fast BLA Review ⁠https://insights.citeline.com/pink-sheet/product-reviews/us-fda-says-ai-played-supporting-summarizing-role-in-fast-bla-review-EKFWWY5SGZFVPL6PVKJVHJOVBQ/⁠ Acting CDER Director Warns AI Over-Reliance Will Trigger GMP Violations ⁠https://insights.citeline.com/pink-sheet/advanced-technologies/ai/acting-cder-director-warns-ai-over-reliance-will-trigger-gmp-violations-7UO5KN7SJJBBLPQT7SLT3SWCJI/

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

    5. Juni

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

    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 Administration received during a public hearing on the National Priority Voucher and their potential impact on the program’s future (10:50). More On These Topics From The Pink Sheet US Supreme Court Retains Skinny Labeling System, Backs Hikma Over Amarin: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-supreme-court-retains-skinny-labeling-system-backs-hikma-over-amarin-4LH4TCR2OVHPBPVMUTN4HGRQCE/ Stakeholders Want Clearer Eligibility Criteria For US FDA’s National Priority Voucher Program: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/stakeholders-want-clearer-eligibility-criteria-for-us-fdas-national-priority-voucher-program-LWGMZFB3VZAUHOZIRCPFWH4JCU/ NPV Program Facing Legal Durability Questions As Public Meeting Impacting Its Future Approaches: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-program-facing-legal-durability-questions-amid-loper-bright-decision-YUZ6E4VAJZFYBOEWMRSWRSRAFI/ Grading US FDA’s National Priority Voucher Program After One Year: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/grading-us-fdas-national-priority-voucher-program-after-one-year-UXYNFYXDGFFH7L6WXG7TMRZPEQ/ CNPV Public Meeting Questions: US FDA Seeks Talking Points Before Confirming Speakers: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-public-meeting-questions-us-fda-seeks-talking-points-before-confirming-speakers-NOZ3QRCLZZCI5K7EXYWKKP7PFY/

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

    29. Mai

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

    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 Agreement Could Include US FDA Pre-Decisional Memos: https://insights.citeline.com/pink-sheet/product-reviews/proposed-government-nondisclosure-agreement-could-include-us-fda-pre-decisional-memos-BTEWGHSQBZGVDCXOCH77CDU7LU/ US FDA Hiring Push Threatens Industry Efforts To Contain, Lower User Fees: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-hiring-push-threatens-industry-efforts-to-contain-lower-user-fees-X5GTZH4JEVD3NPREWLMWKCVB6Q/

    23 Min.
  6. Drug Fix: Post-Mortem On Martin Makary’s Tenure As FDA Commissioner

    15. Mai

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

    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 (29:12) and the pressure on the Trump Administration pick the correct replacement (36:35).  #pharma #business More On These Topics From The Pink Sheet Makary’s Exit Resurrects Questions About US FDA’s Direction Under Trump Administration: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-goes-embattled-us-fda-commissioner-resigns-amid-white-house-special-interest-anger-L4P6P4OSWJHB3GFOIMKVPWQTFU/ PhRMA CEO Backs Parts Of Makary’s US FDA Agenda As Diamantas’ Onboarding Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/phrma-ceo-backs-parts-of-makarys-us-fda-agenda-as-diamantas-onboarding-continues-4UOZPQZOEJEWDEWB7CYMN5VL5M/ What Does Declining Average Commissioner Term Length Say About US FDA’s Future?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/what-does-declining-average-commissioner-term-length-say-about-us-fdas-future-LUWPQ4AW4BGQPPK3EKYCQ6D5OQ/ Trump Plan To Oust Makary Clouds Future Of ‘Bold Reforms’ At US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trump-plans-to-oust-makary-clouds-future-of-bold-reforms-at-us-fda-AJNPZFEHNFEOXG4J7DJMO4E7QI/

    40 Min.
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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/

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