All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-D-1255
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
Documents
5
Comments
33
Key Dates
Comment Period OpensApr 15, 2026
Comment Period ClosesJul 15, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Comment Statistics
Total Comments
33
Keywords
CBER
2026-30
Safety Assessment of Genome Editing in Human
Gene Therapy Products Using Next-Generation
Sequencing
Draft Guidance for Industry
Data from Regulations.gov