pharmaphorum December 2, 2025
The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.
According to the US regulator, agentic AI – autonomous systems capable of independent decision-making – can now be used to make “more complex AI workflows […] to assist with multistep tasks.”
That includes meeting management, pre-market reviews, review validation, post-market surveillance, inspections, and compliance and administrative functions, according to the agency, which also told Stat that the rollout is currently exploratory and the agentic systems will not make regulatory decisions or replace human judgment.
The FDA’s announcement further stressed that the models “do not train on input data nor any data submitted by regulated industry,...
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