French Police Search Drug Regulator's Premises Over Phase I FAAH Study
French regulator ANSM is under scrutiny following a visit by police investigating the tragic Phase I FAAH inhibitor study, and confirms that it carried out an "internal investigation" whose results have been passed to police and the social affairs inspectorate.
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French prosecutors are beginning judicial proceedings into possible manslaughter following the Phase I trial tragedy in January this year, although CRO Biotrial says the move is "a normal decision" in a complex investigation.
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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