FDA expands artificial-intelligence capabilities with “agentic” AI deployment

2nd December 2025

FDA expands artificial-intelligence capabilities with “agentic” AI deployment

Summary: The FDA has begun deploying agentic-AI capabilities to its employees, enabling them to build AI-driven workflows to assist with complex, multi-step tasks. This builds on earlier generative-AI pilot work and the agency-wide introduction earlier in 2025 of an AI tool named Elsa that supports scientific review. The agentic-AI systems operate in a secure environment, with human oversight to ensure data security and compliance. According to the FDA, this deployment aims to reduce routine workload, speed up regulatory reviews and inspections, and improve overall operational efficiency, while preserving rigorous standards. 

Link: FDA expands artificial-intelligence capabilities with agentic AI deployment

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