Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration-Reference-Cited by-同舟云学术

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration

Published:2012-02-22 Issue:6 Volume:21 Page:565-570
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Brajovic Sonja¹,Piazza-Hepp Toni¹,Swartz Lynette¹,Dal Pan Gerald¹

Affiliation:

1. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring; MD; USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference10 articles.

1. Role of Postmarketing Surveillance in Contemporary Medicine;Woodcock;Annu Rev Med,2011

2. FDA guidance for industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment 2005 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf

3. MedWatch form can be downloaded at: MedWatch the FDA safety information and adverse event reporting program - reporting serious problems to FDA http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

4. Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008;McMahon;Pharmacoepidemiol Drug Saf,2010

5. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting;Linder;Pharmacoepidemiol Drug Saf,2010

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