General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
FDA-2025-D-6131-0002Other
Comments
125
Last activity Jun 18, 2026
Deadline
Closed on May 19, 2026
Closed May 19, 2026
Net supportiSupport minus oppose · campaigns included
+82%
+82% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
- Posted
- Mar 19, 2026
- Comment period
- Mar 19, 2026 – May 19, 2026
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
+82%
Net support
Support112Oppose9Other4
Aggregates include form-letter campaigns. Excluding them, net support is +82% across organic comments.
Who commented
Breakdown by commenter type.
Academic
3
Business
29
Individual
45
Trade association
2
Advocacy
40
Other
6
Comments over time
Weekly arrivals, stacked by stance.
Posted Mar 19, 2026Deadline May 19, 2026
Mar 16Mar 30Apr 20May 4May 18Jun 15
Support112Oppose9Other4
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
80%
11%
9%
Advocacy
100%
0%
0%
Business
97%
3%
0%
Other
67%
33%
0%
Academic
67%
33%
0%
Trade association
100%
0%
0%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Animal testing alternatives61
Nam weight-of-evidence frameworks58
Nam validation requirements50
Animal model necessity44
In silico modeling inclusion13
Nam data infrastructure standards6
Cell culture and donor requirements5
Modular validation strategies2
Nam-based biomarker glossary2
Excipient scope inclusion1
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Uncheck an issue to choose another.
| Organization | Animal model necessity | Animal testing alternatives | Cell culture and donor requirements | In silico modeling inclusion | Nam data infrastructure standards |
|---|
28 organization-typed comments could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.