EPISODE · Jun 5, 2026 · 28 MIN
Drug Fix: SCOTUS Rules On Generic Skinny Labels, US FDA’s NPV Faces Uncertain Future
from Citeline Podcasts · host Norstella
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/
What this episode covers
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/
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Drug Fix: SCOTUS Rules On Generic Skinny Labels, US FDA’s NPV Faces Uncertain Future
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