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The FDA announced it will continue its speedy push into the AI unknown with new “agentic AI capabilities” to support a range of regulatory work including pre-market reviews, review validation, post-market surveillance, inspections, and compliance. An agency spokesman told me that all regulatory decisions will ultimately be in the hands of staff.

You may remember that the FDA, earlier this year, launched Elsa, an LLM-based tool to support agency staff. Early users reported the errors and fabulation s that come along with LLM-based tech. FDA now claims over 70% of staff have used t

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