Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
🏛 Food and Drug Administration (FDA)FDA-2026-D-1255
Documents
1
Total comments
33
all analyzed
Comment status
Open
Last activity
Jul 14, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
OtherApr 15, 2026
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for IndustryClosed on Jul 15, 2026💬 33 comments