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Clinical Trial Expedited Safety Report

Known as: Investigational New Drug (IND) Safety Report, CIOMS Report, MedWatch 
Records describing relevant findings and notifications of unexpected serious adverse reactions and other safety information, which is submitted by a… 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2017
2017
Amid Reports of Infant Deaths, FTC Cracks Down on Homeopathy While FDA Investigates.
  • Jennifer Abbasí
  • Journal of the American Medical Association (JAMA…
  • 2017
  • Corpus ID: 19752354
Last August, an infant was rushed from her home to a hospital after seizing for about 25 minutes. Unresponsive, she began to turn… 
2011
2011
Sodium oxybate post-marketing surveillance.
  • N. Feldman
  • Journal of clinical sleep medicine : JCSM…
  • 2011
  • Corpus ID: 37495875
As a condition of approval, the Food and Drug Administration required the manufacturer of Xyrem (sodium oxybate; Jazz… 
2011
2011
Severe muscle cramps after intravenous administration of amiodarone--a novel, potentially dose-dependent adverse effect.
Amiodarone is a widely available anti-arrhythmic agent used to treat both ventricular and refractory supra-ventricular… 
2010
2010
Experts describe "spectrum" of epilepsy.
  • T. Hampton
  • Journal of the American Medical Association (JAMA…
  • 2010
  • Corpus ID: 205015969
the information necessary for an adverse event report from an online posting, and in verifying the identity and motivation of the… 
2005
2005
How to avoid another 'Vioxx'
Flaws in the regulatory system are apparent, but how to rectify them remains unclear. 
2003
2003
MedWatch: managing risks at the FDA.
2002
2002
Auftreten von Tuberkuloseerkrankungen unter der Therapie mit dem Tumor Nekrose Faktor-α neutralisierenden Antikörper Infliximab Referierte Originalarbeit: Keane J, Gershorn S, Wise RP et al. (2001…
  • C. Antoni
  • Zeitschrift für Rheumatologie (Print)
  • 2002
  • Corpus ID: 10870330
2000
2000
Reporting adverse events and product problems. MedWatch provides comprehensive resource for health professionals.
1998
1998
Herbal and Related Remedies
Herbal and related remedies are becoming increasingly popular in the United States. Although some of these products have been… 
1991
1991
Ethics and Epidemiology International Guidelines : Proceedings of the Xxvth Cioms Conference, Geneva, Switzerland, 7-9 November 1990