Clinical Trials in Ireland: Is Ireland The Place To Be?
Significant progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting of clinical trials. Patients, researchers, academics, clinicians and industry along with the Health Research Board have worked tirelessly to develop...
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EMA Guidelines on First in Human Trials Revised
The EMA guidelines on first in human clinical trials have been revised. The European Medicines Agency issued its proposed revisions to the 2007 guideline earlier this week (November 15th).
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A Tightening of Regulations for Phase I Clinical Studies?
The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase (FAAH) inhibitors under investigation in the US. The investigation comes in the aftermath of a Phase I clinical trial in France, in which...
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FDA Seeks Input on New Technology for Conducting Clinical Trials
Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting clinical trials. As clinical trials continue to evolve, the FDA wishes to identify new opportunities to study investigational products and...