Comment from First Ascent Biomedical

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Summary: James Foote, CEO of First Ascent Biomedical, Inc., supports the Expedited Investigational New Drug (IND) Pilot Program but urges the FDA to be more ambitious in its scope. He argues that the FDA should modernize its evidentiary standards to recognize human-derived functional evidence as translational data and establish a pathway for platform diagnostics to support new indications for already approved drugs.
Docket No. FDA-2026-N-4699

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