Alliance for Regenerative Medicine
AdvocacySupport
Rare disease flexibility
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
FDA-2026-D-1255-0002Other
Comments
33
Last activity Jul 14, 2026
Deadline
Closed on Jul 15, 2026
Closed Jul 15, 2026
Net supportiSupport minus oppose · campaigns included
+85%
+85% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
- Posted
- Apr 15, 2026
- Comment period
- Apr 15, 2026 – Jul 15, 2026
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
+85%
Net support
Support30Oppose2Other1
Aggregates include form-letter campaigns. Excluding them, net support is +85% across organic comments.
Who commented
Breakdown by commenter type.
Academic
5
Business
10
Individual
6
Advocacy
3
Trade association
6
Other
3
Comments over time
Weekly arrivals, stacked by stance.
Posted Apr 15, 2026Deadline Jul 15, 2026
Apr 13May 11Jun 15Jul 6Jul 13
Support30Oppose2Other1
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Business
100%
0%
0%
Individual
67%
17%
17%
Trade association
100%
0%
0%
Academic
100%
0%
0%
Advocacy
67%
33%
0%
Other
100%
0%
0%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Choose up to five.
| Organization | Rare disease flexibility | Bioinformatics workflow traceability | Off-target detection sensitivity | Optical genome mapping (ogm) |
|---|---|---|---|---|
Alliance for Regenerative Medicine AdvocacySupport The Alliance for Regenerative Medicine (ARM) supports the FDA's draft guidance on the safety assessment of genome editin | · | · | · | |
CureDuchenne AdvocacySupport CureDuchenne, an advocacy organization for Duchenne muscular dystrophy, supports the FDA's draft guidance on genome edit | · | · | · | |
Genedata BusinessSupport Genedata provides constructive feedback on the draft guidance regarding NGS-based safety assessments for genome editing | · | · | · | |
SeQure BusinessSupport SeQure, a contract research organization, supports the draft guidance and suggests specific improvements regarding minim | · | · |
CureDuchenne
AdvocacySupport
Rare disease flexibility
Genedata
BusinessSupport
Bioinformatics workflow traceability
SeQure
BusinessSupport
Off-target detection sensitivity
Optical genome mapping (ogm)
Comments
Explorer
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- Jul 14, 2026Comment from Timothy BarrySupportAcademic
Researchers from Boston Children's Hospital and Massachusetts General Hospital support the draft guidance but argue that the sections on experimental design and statistical analysis are underdeveloped. They recommend specific improvements regarding the distinction between observed and unobserved editing rates, the use of prospective power analyses, and the reporting of statistical measures of uncertainty.
Read comment → - Jul 13, 2026Comment from Centre for Commercialization of Regenerative Medicine (CCRM)SupportBusiness📎 Attachment
CCRM, a business entity, supports the draft guidance but requests specific clarifications and improvements to ensure consistent, risk-based decision-making. They advocate for clearer definitions regarding NGS sensitivity, integration site analysis, and sample selection to improve regulatory efficiency and scientific rigor.
Read comment →