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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.
2018
2018
Corneal Infections Associated with Sleeping in Contact Lenses — Six Cases, United States, 2016–2018
Contact lenses, when worn and cared for properly, are a safe and effective form of vision correction used by an estimated 45… 
Review
2015
Review
2015
Analysis of reference sources used in drug-related Wikipedia articles.
OBJECTIVE References from drug-related Wikipedia articles and a drug information database were compared. METHODS Drugs in Food… 
Review
2013
Review
2013
Feasibility of Proactive Medical Device Surveillance: The VA Clinical Assessment Reporting and Tracking (CART) Program
Background: Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs… 
2012
2012
Hemorrhagic stroke in young healthy male following use of sports supplement Jack3d.
A 26-year-old male was presented to a military treatment facility in Afghanistan shortly after taking a weight-lifting supplement… 
2005
2005
How to avoid another 'Vioxx'
Flaws in the regulatory system are apparent, but how to rectify them remains unclear. 
Review
2005
Review
2005
Toxicity and drug interactions associated with herbal products: ephedra and St. John's Wort.
2003
2003
An independent assessment of MEDWatch reporting for abuse/dependence and withdrawal from Ultram (tramadol hydrochloride).
Review
1999
Review
1999
Unusual distributions of body fat in AIDS patients: a review of adverse events reported to the Food and Drug Administration.
This report summarizes postmarketing adverse events reported to the Food and Drug Administration (FDA) that describe unusual or… 
Review
1995
Review
1995
Serious Adverse Events in Norplant Users Reported to the Food and Drug Administration's MedWatch Spontaneous Reporting System
1995
1995
Serious adverse events in Norplant users reported to the Food and Drug Administration's MedWatch Spontaneous Reporting System.
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