On January 6, 2025, the FDA issued draft guidance on applying artificial intelligence to drug and biologics development, responding to a marked uptick in AI-based regulatory submissions. For the purposes of the draft guidance, AI “refers to a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments.”
The draft guidance introduces a potential seven-step, risk-based framework for evaluating the credibility of AI models and includes recommendations for maintaining model performance over its life cycle. While it excludes drug discovery and operational efficiencies, it focuses on how AI-generated data can support regulatory decisions on a drug’s safety, effectiveness, and quality. Concurrently, on January 7, 2025, the FDA issued a separate draft guidance on marketing submissions for devices with AI-enabled software functions. Public comments on both documents are open for 90 days.