Subjects: Adverse Drug Reaction Reporting Systems - Digital Collections - National Library of Medicine Search Results

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Start Over Subjects Adverse Drug Reaction Reporting Systems

1. 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 Systems
Drug and Narcotic Control
Electronic Mail
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. 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 Systems
Drugs, Investigational -- adverse effects
Drugs, Investigational -- therapeutic use
United States
United States. Food and Drug Administration