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Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry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- Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry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Alliance for Regenerative Medicine AdvocacySupport The Alliance for Regenerative Medicine (ARM) supports the FDA's draft guidance on the safety assessment of genome editin | · | · | · | |
CureDuchenne AdvocacySupport CureDuchenne, an advocacy organization for Duchenne muscular dystrophy, supports the FDA's draft guidance on genome edit | · | · | · | |
Genedata BusinessSupport Genedata provides constructive feedback on the draft guidance regarding NGS-based safety assessments for genome editing | · | · | · | |
SeQure BusinessSupport SeQure, a contract research organization, supports the draft guidance and suggests specific improvements regarding minim | · | · |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
Every mirrored comment — filter by stance, campaign, or issue.