Comment from Anthropic

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Summary: Anthropic, an AI safety and research company, supports the FDA's pilot program but recommends a framework that distinguishes between the obligations of the AI tool sponsor and the developer of the underlying general-purpose model. They argue for architecture-neutral technology selection, structured provenance documentation for training data, and a managed lifecycle for model versioning rather than a general requirement to freeze model versions during a trial.
Please see the attached comment letter of Anthropic PBC in response to Docket No. FDA-2026-N-4390, AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information (91 FR 23100, April 29, 2026).

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