January 16th, 2013
According to the New York Times, St. Jude is failing to comply with concerns that the F.D.A. has over the Durata which links the embedded defibrillator to a person’s heart. These concerns were voiced by the F.D.A. in the fall of 2012 when the company factory was inspected. Until St. Jude addresses the F.D.A.’s concerns, no applications for advanced medical devices will be approved. St. Jude insists that their medical equipment works well but the F.D.A. disagrees, saying their patience with St. Jude is running out. The F.D.A. is allowing St. Jude 15 days to create a plan for how they are going to address these concerns with the Durata.
To find out more visit The New York Times.