FDA AI Drug/Bio Guidance
FDA AI/ML in Drug Development and Manufacturing — Discussion Papers and Framework
United States · FDA Discussion Paper (May 2023); CDER/CBER Draft Guidance (Jan. 2025)
- Status
- In effect
- Took effect
- May 10, 2023
- Applies to
- Sponsors of drug and biological product applications using AI/ML in development or manufacturing
- Enforced by
- FDA Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research
FDA published a framework setting expectations for how drug and biologics companies use AI/ML across drug discovery, clinical trials, postmarket safety surveillance, and manufacturing. The framework signals that AI used in regulatory submissions must be transparent, validated, and reproducible.
Who is protected: Patients enrolled in clinical trials and consumers of AI-developed or AI-manufactured drugs/biologics
Legal detail
FDA CDER/CBER Discussion Paper, 'Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products' (May 2023), and follow-on draft guidance, 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products' (Jan. 2025), define a risk-based credibility framework for AI models used in regulatory submissions.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Limited |
| Enacted | May 10, 2023 |
| Citation | FDA Discussion Paper (May 2023); CDER/CBER Draft Guidance (Jan. 2025) |
| Private right of action | No, agency enforcement only |
| Penalties | Clinical hold; application refusal; manufacturing enforcement actions |
| Topics | healthcare AI · automated decision-making · AI disclosure and transparency |
| Agency page | FDA Discussion Paper — AI/ML in Drug Development and Manufacturing (May 2023) |
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