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French Trial Tragedy: Experts Recommend Tighter Phase I Rules

This article was originally published in Scrip

Executive Summary

The French committee investigating the data behind the Phase I study of Bial's FAAH inhibitor BIA 10-2474, which resulted in the death of one volunteer and the hospitalization of five others in January 2016, has made a number of recommendations for tightening up the regulations on first-in-human studies.

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