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FDA Webinar: Safety Assessment of Genome Editing in Gene Therapy

Food and Drug Administration, Office of Therapeutics Products · June 23, 2026

FDA presenter Komudi Singh outlined a newly published draft guidance recommending how developers should use next-generation sequencing (NGS) in nonclinical safety assessments of human genome‑editing products, and invited public feedback at the docket.

AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.