RegDivergence-101: An LLM Benchmark for Cross-Jurisdiction Regulatory Contradiction Detection in Life Sciences

Abstract

arXiv:2608.28607v1 Announce Type: new Abstract: Pharmaceutical sponsors developing a drug for both the United States and the European Union must reconcile guidance issued independently by the FDA and the EMA. Where the two agencies require substantively the same thing, a sponsor can file once; where they diverge, a single trial design risks rejection in one region; where one agency is silent on a point the other regulates, the sponsor must infer obligations. Today this reconciliation is performe