US FDA Announces Draft Guidance on AI Use in Regulatory Decision-Making for Drug and Biological Products

Us Fda Announces Draft Guidance Ai Use Regulatory Decision Making Drug Biological Products

On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.” This draft guidance marks an important step toward integrating artificial intelligence (AI) into the regulatory decision-making process for drugs and biological products, emphasizing safety, effectiveness, and quality assessments. Through this initiative, the FDA aims to establish a risk-based framework to evaluate the credibility and reliability of AI models in regulatory contexts.

The FDA’s guidance highlights several critical components:

1. A Risk-Based Credibility Framework

AI models must be assessed based on their intended use, or context of use (COU), with varying levels of oversight and stringency depending on the potential impact on patient safety or study reliability.

Key factors include:

  • Performance criteria
  • Risk mitigation strategies
  • Tailored documentation requirements

2. Scope of AI Applications

The guidance focuses on AI’s role in nonclinical, clinical, post marketing, and manufacturing phases, specifically for regulatory decisions related to drug safety, effectiveness, and quality.
Excluded from the guidance are:

  • AI in drug discovery
  • Applications enhancing operational efficiency without direct patient or study impacts

3. Early Engagement with FDA

The FDA strongly encourages sponsors to engage early, especially for higher-risk applications like post marketing pharmacovigilance. Clear documentation and alignment with the agency’s expectations are key to a smooth evaluation process.

4. Encouraging Innovation in Pharmacovigilance

To foster innovation, the FDA has also launched the Emerging Drug Safety Technology Meeting (EDSTM) Program, a platform for discussing new technologies and their potential applications in pharmacovigilance.

The FDA is calling on industry leaders, researchers, and other stakeholders to provide feedback on the draft guidance by April 7, 2025.

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