FDA draft guidance: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

Summary

FDA draft guidance issued January 6, 2025 (docket FDA-2024-D-4689) for sponsors and other parties using AI to produce information or data that supports regulatory decisions about the safety, effectiveness or quality of drugs and biological products. It proposes a risk-based credibility assessment framework for establishing and evaluating an AI model's credibility for a particular context of use. FDA described it as its first guidance on AI in drug and biological product development. It remains a draft.

Key dates

1. January 6, 2025Issued
2. October 16, 2026Checked against sources
3. October 21, 2026Checked against sources

Developments are added when the record is reviewed. Next review: January 15, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

1. For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product's safety, effectiveness or quality.

   Supports: Issue date and scope

   FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions U.S. Food and Drug Administration Primary source

2. this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).

   Supports: Credibility framework

   Draft Guidance for Industry and Other Interested Parties January 2025 Download the Draft Guidance Document

   Supports: Still a draft

   Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products U.S. Food and Drug Administration Primary source

3. The risk-based credibility assessment framework proposed within the draft guidance is informed by

   Supports: Federal Register notice, January 7, 2025

   Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance; Availability (FR Doc. 2024-31542) Federal Register (govinfo) Primary source