FDA outlines AI governance, pilots and how artificial intelligence will support rare‑disease review FDA panels detailed internal AI tools (ELSA, Gemini), governance councils, pilot projects and center‑level AI use cases ranging from submission triage to device monitoring. Officials reiterated a human‑in‑the‑loop, risk‑based approach and urged early engagement from sponsors.

The FDA is harnessing the power of AI to revolutionize the review process for rare-disease products, ensuring faster, more consistent evaluations while keeping human oversight at the forefront.

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