Lexology January 21, 2025
The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which provides a comprehensive, risk-based framework to help sponsors evaluate and manage AI models. The guidance applies to the nonclinical, clinical, postmarketing, and manufacturing phases of the product lifecycle; while notably excluding from its scope AI use for drug discovery and operational efficiencies that do not impact patient safety, drug quality, or the reliability of results from a nonclinical or clinical study. By implementing the recommended credibility assessment plans and submitting credibility assessment reports as described by the guidance, drug and biologic sponsors can establish robust documentation that validates their...
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