FDA researchers present pilot LLM tools to speed regulatory review; internal tests show promising accuracy At an FDA Grand Rounds, Dr. Hsu of NCTR outlined four pilot applications of large language models for regulatory review — literature screening, an Ask‑FDA documents chatbot, labeling AE detection, and duplicate AE identification — reporting internal benchmarks that suggest notable efficiency gains.

Dr. Hsu reveals how cutting-edge AI tools could revolutionize FDA regulatory reviews, boosting efficiency and accuracy in life-saving assessments.

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