Regulatory Deadline Board/2026-21954
Food and Drug Administration · Notice
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability
29 days left
In plain English
FDA draft guidance explains when multiple variants of an individualized human genome-editing product can sit in one BLA, and how to manage them after approval.
Who it hits
Gene-editing sponsors, advanced therapy manufacturers, and BLA regulatory teams.
- Agency
- Food and Drug Administration
- Document type
- Notice
- Published
- Oct 28, 2026
- Comments close
- Nov 27, 2026
- Status
- 29 days left
- Federal Register number
- 2026-21954
- Docket
- Docket No. FDA-2026-D-11783
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