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GUIDANCE DOCUMENT

Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products Draft Guidance for Industry and Other Interested Parties January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-4689
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Inspections and Investigations
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products

This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, 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).

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4689.

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