The FDA has launched agentic AI capabilities for all agency staff, marking an expansion of its internal AI infrastructure.
Agentic AI refers to systems that can plan, reason and carry out multi-step tasks while incorporating human oversight. The tools will assist FDA employees with complex workflows such as inspections, compliance, pre- and post-market reviews, and administrative functions, according to a Dec. 1 news release from the agency. Use of the tools is voluntary.
The deployment builds on the agency’s June rollout of Elsa, a generative AI tool in use by more than 70% of FDA employees. Elsa is designed to help speed up clinical trial reviews, summarize adverse events, perform label comparisons and generate code for internal databases. Both tools operate in GovCloud, a secure environment that excludes training on data from regulated industry.
FDA Commissioner Marty Makary, MD, said in the release the tools will support reviewers, scientists and investigators in accelerating cures and treatments. Chief AI Officer Jeremy Walsh said agentic AI will help streamline work while maintaining product safety and efficacy.
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