Day: July 2, 2015

Some Warning Letters demonstrate that quality of training of FDA Inspectors. FDA Inspectors are trained to pay close attention to seemingly minor observations to catch errant manufacturers. Recently, in a Warning Letter issued to a manufacturer of oxygen tanks, Trans Ox located at West Columbia, South Carolina, FDA inspectors identified several discrepancies in documents and gross violations … Read more

Since the launch of the Breakthrough (BT) designation program by FDA in July 2012, there have been more than 200 requests for this designation just to CDER, along with several additional to CBER. FDA granted about one-third of the requests, and rejected the other applications for either lack of clinical evidence, safety issues, or no significant improvement … Read more