Adverse Event Reporting System AERS

Adverse drug events (ADE) FDA Adverse Event Reporting System (AERS) http //www.fda.gov/cder/aers/default.htm Safety reports... 

To identify case reports containing information on drug and grapefruit juice interaction, the Adverse Event Reporting System (AERS) (2) database... 

U.S. Food and Drug Administration, Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January-March 2008, FDA. Available online. URL http //www.fda. gov/Oder/aers/potential signals/potential signals 2008Q1. htm. Updated Febru-ary 4, 2009. 

FDA ESG This document provides an overview of the process of electronic submissions and provides registration and confirmation processes as well as links to electronic submission requirements of the Center for Biologies Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), the Adverse Events Reporting System (AERS), and the Center for Devices and Radiological Health (CDRH). 

Food and Drug Administration. (1999, July 2). Adverse Event Reporting System (AERS) Freedom of Information (FOI) report. Rockville, MD Center for Drug Evaluation and Research. 

Information received through the MedWatch program is entered into the Adverse Event Reporting System (AERS) database. The AERS database is designed to permit electronic or paper submission of reports, comply with international standards and terminology, and facilitate pharmacovigilance screening. In addition to the... 

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