FDA Deploys Agentic AI Capabilities for Agency Employees

December 1, 2025, 8:14 PM UTC

The FDA deployed agentic AI Capabilities for agency employees to assist with more complex tasks.

  • Tasks include meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions
  • The models do not train on input data nor any data submitted by regulated industry
  • LLM-based tool, Elsa, is used by more than 70% of staff, per the agency

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To contact the reporter on this story:
Andrew Mendez in San Francisco at amendez112@bloomberg.net

To contact the editor responsible for this story:
Ilya Banares at ibanares@bloomberg.net

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