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/

Episodes

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

    2d ago

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

    May 29

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

    May 15

    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
  • 3 Episodes

About

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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