1. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023 Subject(s): Biological ProductsCompassionate Use TrialsDrug IndustryDrugs, InvestigationalEthics Committees, ResearchGovernment RegulationUnited States
