Pink Sheet Podcast: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms
Executive Summary
Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss former US Surgeon General Jerome Adams’ view that additional regulation is necessary to ensure industry complies with clinical trial diversity requirements (:27), as well as questions about the US Food and Drug Administration potentially approving Zevra Denmark A/S’ arimoclomol in Niemann-Pick disease type C, but with an unapproved standard-of-care regimen (15:00). They also consider any adjustments sponsors and others may encounter when the FDA returns to fully in-person advisory committee meetings in September (24:03).
More On These Topics From The Pink Sheet
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‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity
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Zevra’s Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment
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Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel
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