Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry
FDA-2025-D-1504-0002Other
Comments
42
Last activity Jun 21, 2026
Deadline
Closed on May 9, 2026
Closed May 9, 2026
Net supportiSupport minus oppose · campaigns included
+76%
+76% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry
- Posted
- Mar 9, 2026
- Comment period
- Mar 9, 2026 – May 9, 2026
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
+76%
Net support
Support36Oppose4Other2
Aggregates include form-letter campaigns. Excluding them, net support is +76% across organic comments.
Who commented
Breakdown by commenter type.
Academic
1
Business
8
Individual
16
Trade association
4
Advocacy
12
Other
1
Comments over time
Weekly arrivals, stacked by stance.
Posted Mar 9, 2026Deadline May 9, 2026
Mar 9Mar 23Apr 13Apr 27Jun 15
Support36Oppose4Other2
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
75%
13%
13%
Advocacy
100%
0%
0%
Business
88%
13%
0%
Trade association
75%
25%
0%
Academic
100%
0%
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 | Attorney-client privilege and disclosure | Foreign inspection oversight | Response format and content | Scope of guidance application |
|---|
4 organization-typed comments could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.