1. Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees Publication: Washington, D.C. : U.S. Government Accountability Office, July 2017 Subject(s): Adverse Drug Reaction Reporting SystemsDrugs, Investigational -- adverse effectsDrugs, Investigational -- therapeutic useDrug ApprovalHealth Services AccessibilityHumansUnited StatesUnited States. Food and Drug Administration.
2. E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022 Subject(s): Adverse Drug Reaction Reporting SystemsDrug and Narcotic ControlElectronic MailUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
