CognifAI Solutions Pvt Ltd.
BusinessSupport
Ai and ml validation guidelines
Bias and fairness
Model life cycle maintenance
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance
FDA-2024-D-4689-0003Other
Comments
123
Last activity Jun 6, 2026
Deadline
Closed on Apr 8, 2025
Closed Apr 8, 2025
Net supportiSupport minus oppose · campaigns included
+89%
+89% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance
- Posted
- Jan 7, 2025
- Comment period
- Jan 7, 2025 – Apr 8, 2025
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Analyzed 87 of 123 comments
71%· analysis in progress
Stance breakdown
+89%
Net support
Support79Oppose2Other6Not yet analyzed36
Aggregates include form-letter campaigns. Excluding them, net support is +89% across organic comments.
Who commented
Breakdown by commenter type.
Government
1
Individual
30
Advocacy
16
Trade association
7
Academic
5
Business
22
Other
6
Not yet analyzed
36
Comments over time
Weekly arrivals, stacked by stance.
Posted Jan 7, 2025Deadline Apr 8, 2025
Jan 6Feb 3Feb 24Mar 31May 5Dec 15May 11Jun 1
Support79Oppose2Other6
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
80%
7%
13%
Business
100%
0%
0%
Advocacy
94%
0%
6%
Trade association
86%
0%
14%
Other
100%
0%
0%
Academic
100%
0%
0%
Government
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
Uncheck an issue to choose another.
| Organization | Ai and ml validation guidelines | Bias and fairness | Model life cycle maintenance | Combination products | Definition of ai |
|---|---|---|---|---|---|
CognifAI Solutions Pvt Ltd. BusinessSupport CognifAI Solutions Pvt Ltd. | · | · |
11 organization-typed comments could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
Filter:
- Apr 7, 2025Comment from George EvgrafovSupportIndividual
The commenter suggests that the FDA clarify the scope of the guidance to include AI systems used to generate or transform data submitted to the Agency, even if their primary purpose is operational. They argue this will improve alignment and prevent misclassification of AI systems.
Read comment → - Jan 15, 2025Comment from Joshua BishopOpposeIndividualRead comment →