View from Brussels

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Articles

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies. 


Rare disease stakeholders speak out ahead of anticipated EU changes.

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

New EU clinical trial regulation places heavy importance on patient-submitted documents.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

Proposed US merger could threaten innovation in cancer diagnosis, Commission officials assert.

Commission pushes for a “more unified” approach to drug development following a period of fragmented coordination during the pandemic. 

Orientation pursuits hit high gear as formal rule compliance inches closer.

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.