arXiv AI By Betty Xiong, Jillian Fisher, Benjamin Newman, Meng Hu, Shivangi Gupta, Yejin Choi, Lanyan Fang, Russ B Altman

FDARxBench: Benchmarking Regulatory and Clinical Reasoning on FDA Generic Drug Assessment

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FDARxBench is an expert‑curated benchmark designed to evaluate document‑grounded question answering on FDA drug label documents, focusing on generic drug assessment. It features a multi‑stage pipeline that generates high‑quality QA examples covering factual, multi‑hop, and refusal tasks, and includes protocols for both open‑book and closed‑book reasoning. Experiments with various language models show significant gaps in factual grounding, long‑context retrieval, and safe refusal behavior, highlighting the challenge of regulatory‑grade label comprehension.

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