FDA Deploys Agentic AI to Modernize Regulatory Workflows

The U.S. Food and Drug Administration (FDA) has taken a substantial step in its digital modernization strategy with the deployment of agentic artificial intelligence capabilities across all agency employee groups. The move represents an expansion of the agency’s internal AI tools, intended to streamline complex, multi-step processes that support regulatory science, product review, and compliance activities. The deployment strengthens the FDA’s ongoing effort to embed structured, secure, and transparent AI systems into daily workflows, building on the rapid adoption of the LLM-based tool Elsa earlier this year.