Newsletter - July 2, 2015
The Breakthrough Designation Can be Withdrawn or Rescinded by FDA
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 over existing therapies. Once a company successfully gets the BT designation, it is cause of major uptick in the value of the product due to scientific validity of the program and potential faster market approval. Some analysts have set the valuation of BT designation to hundreds of millions of dollars. So, obviously this designation is very precious. However, it is not a permanent designation. Read More...
FDA Inspectors = Sherlock Holmes: FDA Inspector to Find Major Issues with GMP Compliance by Paying Close Attention to Details
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 of GMP regulations. It is not the findings but how FDA detected them that is of interest. In one case, the manufacturer had documented that a portable oxygen analyzer was used to conduct a critical release test, however, FDA inspector noted that between the wall on which the portable oxygen analyzer was hung and the device, there were cobwebs, indicating that the device was never removed from its location. Read More...
The Breakthrough Designation Can be Withdrawn or Rescinded by FDA
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 over existing therapies. Once a company successfully gets the BT designation, it is cause of major uptick in the value of the product due to scientific validity of the program and potential faster market approval. Some analysts have set the valuation of BT designation to hundreds of millions of dollars. So, obviously this designation is very precious. However, it is not a permanent designation. Read More...
FDA Inspectors = Sherlock Holmes: FDA Inspector to Find Major Issues with GMP Compliance by Paying Close Attention to Details
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 of GMP regulations. It is not the findings but how FDA detected them that is of interest. In one case, the manufacturer had documented that a portable oxygen analyzer was used to conduct a critical release test, however, FDA inspector noted that between the wall on which the portable oxygen analyzer was hung and the device, there were cobwebs, indicating that the device was never removed from its location. Read More...
