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NewsFDATuesday, April 14, 2026 · April 14, 2026

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development

WHY IT MATTERS

FDA announcement relevant to rare disease patients and caregivers.

The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies.

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FDA DesignationOrphan Drug

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