FDA Brief : Week of Jan 25, 2016

biotrial.JPG

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

READ

 

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s