1. Informed consent. Guidance for IRBs, clinical investigators, and sponsors Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Ethics Committees, ResearchGovernment RegulationInformed ConsentResearch PersonnelUnited StatesUnited States. Food and Drug Administration
2. 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
