EMA will define its own trial data shortcuts, not just follow FDA
This article was originally published in Scrip
The European Medicines Agency is pressing on with plans to develop a formal framework on how companies may gauge the effects of an investigational drug on a target population by extrapolating available data from related studies involving other populations, thereby avoiding the need to conduct unnecessary clinical studies. But discussions at a recent meeting suggest it will not simply adopt wholesale the approach that the US FDA has espoused.
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