Great 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 this framework. Yet, with all of these developments, Ireland still only participates in less than […]
Our team of regulatory affairs experts are regarded as the thought leaders in the sector. They have worked on some of the most challenging and ground breaking regulatory projects in modern times. They regularly write for specialist periodicals and speak at industry events. In this, the first edition of ‘Regulatory Intelligence’ we have asked them […]
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).
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 one healthy volunteer died while taking a drug of the FAAH class. A further 4 […]
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 to gain insight into barriers, challenges, and other relevant considerations that may affect the clinical […]