FDA Deploys 'Agentic' AI to Accelerate Drug Regulation
Agency rolls out autonomous tools to staff for pre-market reviews and post-market surveillance.
The U.S. Food and Drug Administration (FDA) announced on Dec. 1, 2025, that it is deploying agentic AI capabilities to all agency employees. This move transitions the regulator from using passive large language models (LLMs) to active agents capable of planning, reasoning, and executing complex multi-step tasks within the regulatory workflow.
From Chatbots to Agents
The deployment builds on the agency's earlier release of "Elsa," an LLM tool voluntarily used by over 70% of staff. - New Capabilities: Unlike standard chatbots, the new agents can autonomously navigate internal databases, verify data across multiple documents, and generate preliminary review summaries. …
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