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
- ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity
- Gaps Found In Most Pharma Trial Diversity Policies
- Zevra’s Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment
- Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel
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