EMA Begins Review Of Phase I Trial Guideline Based On French Inquiry Findings
This article was originally published in SRA
Executive Summary
The European Medicines Agency has begun reviewing its guideline on first-in-human (FIH) trials following the tragic events in France in January this year when the Phase I study with Bial's FAAH inhibitor BIA 10-2474 led to the death of one volunteer and the hospitalization of five others1.