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Drug Approval Process

Known as: Approval Processes, Drug, Approval Process, Drug, Processes, Drug Approval 
National Institutes of Health

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Drug Approval

Papers overview

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Review
2019
Review
2019
[Duration and variation of the ethics approval process in Germany - an example from a non-interventional study with 44 participating centers].
Review
2018
Review
2018
Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience
We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of… 
2017
2017
A Bias in the Evaluation of Bias Comparing Randomized Trials with Nonexperimental Studies
Abstract In a recent BMJ article, the authors conducted a meta-analysis to compare estimated treatment effects from randomized… 
2014
2014
Premarket Approval Supplement Pathway: Do We Know What We Are Getting?
The global medical device industry has dramatically expanded in the past 5 years, with the market expected to be valued at more… 
2009
2009
Effect of low frequency ultrasound on combined rt-PA and eptifibatide thrombolysis in human clots.
2008
2008
The deregulatory effects of preempting tort litigation: FDA regulation of medical devices.
  • L. Gostin
  • Journal of the American Medical Association (JAMA…
  • 2008
  • Corpus ID: 10439779
CHARLES RIEGEL UNDERWENT CORONARY ANGIOplasty in 1996, shortly after sustaining a myocardial infarction. Mr Riegel’s physician… 
Review
2008
Review
2008
Stroke Genetic Research and Adults With Impaired Decision-Making Capacity: A Survey of IRB and Investigator Practices
Background and Purpose— In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity… 
Review
2007
Review
2007
Canadian University Ethics Review
Drawing from educational research conducted in Canada and Mexico, university researchers explore how culture complicates both the… 
2007
2007
The Burden of Embodied Autonomy : Some Reflections on the Social and Ethical Implications of Autonomous Robots
As robot technology is progressing quickly and robots are becoming more sophisticated both in terms of their appearance as well… 
Review
1994
Review
1994
A retrospective analysis of institutional review board and informed consent practices in EMS research.
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