FDA Grand Rounds - Adopting Large Language Models for Regulatory Review
U.S. Food and Drug Administration (FDA) · February 5, 2026
FDA Grand Rounds featured Dr. Hsu of NCTR describing efforts to apply large language models (LLMs) to regulatory review. He reviewed four internal use cases — literature screening, an Ask‑FDA documents chatbot, adverse‑event labeling analysis, and duplicate adverse‑event detection — and shared preliminary performance benchmarks and implementation considerations.
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