Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
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- Title
- Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
- Posted
- Jun 3, 2026
- Comment period
- Jun 3, 2026 – Sep 2, 2026
- Topics
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- Jul 16, 2026Comment from CureDuchenne - Newport Beach, CASupportAdvocacy📎 Attachment
CureDuchenne, a patient advocacy organization for Duchenne muscular dystrophy, strongly supports the FDA's draft guidance on leveraging prior knowledge for genome editing therapies. They argue that streamlining development through shared data and platform experience is critical for addressing urgent unmet needs in rapidly progressive pediatric diseases.
Read comment → - Jun 8, 2026Comment from Samer DahshiAnalysis pending📎 AttachmentRead comment →