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EMA will define its own trial data shortcuts, not just follow FDA

This article was originally published in Scrip

Executive Summary

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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