Expanded Access Study

Known as: EXPANDED ACCESS 
Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not… (More)
National Institutes of Health

Topic mentions per year

Topic mentions per year

2013-2017
02420132017

Papers overview

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2017
2017
We sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in ClinicalTrials.gov… (More)
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2017
2017
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking… (More)
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Review
2017
Review
2017
Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs… (More)
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2016
2016
BACKGROUND The purpose of this study was to describe the experience of the Center of Drug Evaluation and Research (CDER) with… (More)
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2016
2016
BACKGROUND When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it… (More)
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2015
2015
Patient access to experimental drugs outside of clinical trials is called compassionate use or expanded access. Compassionate use… (More)
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Review
2015
Review
2015
Tuberculosis (TB) remains a global emergency and is one of the most common infectious disease causes of death in developing… (More)
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Review
2015
Review
2015
PURPOSE The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill… (More)
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2014
2014
BACKGROUND Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Administration (FDA) approved for… (More)
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2013
2013
The following case contains my comments and not those of Sandoz. My team submitted the New Drug Application (NDA) for LAMIISIL… (More)
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