FDA Brief : Week of Jan 25, 2016


Drug Information Update-FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study

  • Conferring with European regulators regarding the tragic phase 1 clinical study, conducted by Biotrial that resulted in 1 death and 4 neurological injuries
  • BIA 10-2474 is inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system
  • FDA is collecting and reviewing safety information pertinent to FAAH inhibitors in US and will work with sponsors, patients, investigators to ensure safety




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