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
2. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023 Subject(s): Compassionate Use TrialsDevice ApprovalGovernment RegulationGuideline AdherenceUnited States
