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Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

🏛 Food and Drug Administration (FDA)FDA-2024-D-4689
Artificial IntelligencePharmaceutical Policy
Documents
1
Total comments
123
36 awaiting analysis
Comment status
Open
Last activity
Jun 6, 2026
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Rules, notices, and supporting material — the primary rule pinned first.

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📄 Primary document
OtherJan 7, 2025
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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance
Closed on Apr 8, 2025💬 123 comments · 36 awaiting analysis
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