Along with the deployment and integration the new agentic AI tool, FDA is also launching an agentic AI challenge for its ...

FDA rolls out agentic AI tools to assist staff with inspections, reviews, and compliance, enhancing workflow efficiency and oversight.

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated ...

The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems ...

Makary announced in May that he intended for the FDA to fully integrate generative AI into its work by the end of June; that ...

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently demonstrated by the coronation of new generative AI tool Elsa. Now, Makary and ...

The FDA is using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations and identify high-priority inspection targets. The Food and Drug Administration has ...

Under pressure to speed up the review of drugs and medical devices, the Food and Drug Administration is turning to artificial intelligence tools to help its scientific reviewers and investigators ...