Adverse drug event monitoring at the food and drug administration
- 1 January 2003
- journal article
- review article
- Published by Springer Nature in Journal of General Internal Medicine
- Vol. 18 (1), 57-60
- https://doi.org/10.1046/j.1525-1497.2003.20130.x
Abstract
The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The coKeywords
This publication has 29 references indexed in Scilit:
- Concomitant Risk Factors in Reports of Torsades de Pointes Associated with Macrolide Use: Review of the United States Food and Drug Administration Adverse Event Reporting SystemClinical Infectious Diseases, 2002
- Uterine Sarcoma Associated with Tamoxifen UseNew England Journal of Medicine, 2002
- Cerivastatin and Reports of Fatal RhabdomyolysisNew England Journal of Medicine, 2002
- Endocarditis in a Woman With Pulmonary Histiocytosis—CorrectionPublished by American Medical Association (AMA) ,2001
- Spontaneous reports of pulmonary embolism in association with raloxifenePublished by Wolters Kluwer Health ,2001
- An analysis of reports of depression and suicide in patients treated with isotretinoinJournal of the American Academy of Dermatology, 2001
- Myocarditis and Cardiomyopathy Associated with Clozapine Use in the United StatesNew England Journal of Medicine, 2001
- Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problemsPublished by American Medical Association (AMA) ,1993
- Canada: Blood transfusion inquiryThe Lancet, 1993
- USA: MEDWatchThe Lancet, 1993