In December 2025, the U.S. Food and Drug Administration (FDA) officially deployed Agentic AI capabilities across all agency teams — marking a major milestone in the modernization of regulatory science. These advanced systems can reason, plan, and execute multi-step workflows, supporting complex functions like review validation, post-market surveillance, compliance, and administrative automation.
Agentic AI represents a new phase of AI maturity — one where intelligent systems go beyond generating insights to orchestrating action within safe, controlled frameworks. The FDA’s launch also includes a two-month Agentic AI Challenge, encouraging staff to create and demonstrate new applications during the upcoming Scientific Computing Day this January 2026.
At Clinakos Inc., we see this moment as transformative for the broader healthcare ecosystem. Our work in AI-driven data intelligence and disease-specific insight platforms is aligned with the same principles driving Agentic AI — collaboration between human expertise and intelligent systems to accelerate discovery, ensure data integrity, and deliver precision insights. 🧬📊
As healthcare agencies and innovators embrace Agentic AI, the potential to streamline reviews, optimize decision-making, and enhance patient outcomes becomes more real than ever.
We want to hear from you: How do you anticipate agentic AI will reshape the future of regulatory submissions and approvals?
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