Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft)

FDA · Draft

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Summary

FDA draft guidance proposing a risk-based credibility framework for AI models whose output supports regulatory decisions about drugs and biologics. Still a draft (docket FDA-2024-D-4689).

Dated events

1. 30 Oct 2026 Checked: still draft; no final guidance found Source for Checked: still draft; no final guidance found
2. 7 Jan 2025 Draft guidance published (comments closed 7 Apr 2025) Source for Draft guidance published (comments closed 7 Apr 2025)

Official source

Official text

Source: FDA. Public domain.