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FDA Sticks to November Deadline for Galidesivir Feedback Despite Shutdown
9:43am on Wednesday 22nd of October, 2025 AEDT
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Pharmaceuticals
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FDA Sticks to November Deadline for Galidesivir Feedback Despite Shutdown
9:43am on Wednesday 22nd of October, 2025 AEDT
Key Points
FDA confirms written feedback by 12 November 2025 despite US government shutdown
Focus on Animal Rule use to expedite Galidesivir approval for Marburg virus
Guidance sought on non-human primate study design and Priority Review Voucher eligibility
Comprehensive briefing package submitted covering clinical and animal study data
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