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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance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.
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- May 20, 2026Comment from Bhasker SambarSupportIndividual📎 Attachment
Bhasker Sambar, a pharmaceutical development and CMC operations manager, provides specific recommendations to improve the draft guidance on AI in regulatory decision-making. He suggests expanding the scope to include combination products, extending practical examples through all steps, clarifying requirements for third-party AI models, and addressing cybersecurity risks.
Read comment → - Apr 7, 2025Comment from Sharif HoqueSupportIndividual
The commenter provides constructive feedback and suggestions to improve the draft guidance on AI in regulatory decision-making. They recommend expanding the scope to include combination products, adding a glossary of terms, and providing more specific examples of model risk categories and GXP impacts.
Read comment → - Apr 5, 2025Comment from International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium, www.iqconsortium.org)SupportTrade association📎 Attachment
The International Consortium for Innovation & Quality in Pharmaceutical Development (IQ) supports the draft guidance, commending its flexible, risk-based framework for using AI in drug and biologic development. They provide numerous specific recommendations to improve the guidance's clarity on software requirements, reproducibility, data management, model evaluation metrics, and regulatory engagement.
Read comment →