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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance

A pharmaceutical or biotechnology sponsor (implied by the use of "sponsors" and "industry" context) supports the draft guidance for using AI in regulatory decision-making. They suggest that the FDA provide further clarification on how to document human accountability and adequacy determinations when AI models are integrated as automated, embedded components of regulatory workflows.

The commenter suggests that the FDA clarify that human-in-the-loop oversight does not exempt AI components from rigorous validation requirements. They argue that models must be validated for accuracy, reliability, and traceability to ensure risks are not underestimated in regulatory decision-making.