Why is the FDA taking so long?

American Gene Technologies® cannot predict how long the FDA process will take at each stage of the human trial and approval process. Due to the breakthrough nature of gene and cell therapies, the FDA is overwhelmed with Investigational New Drug (IND) applications and seems to be understaffed in gene and cell therapy experts to efficiently process applications. While the delay creates frustration, it is important to note that the FDA exists for the safety of patients. Negotiations with the FDA may take time, but the result will hopefully be a well-tested treatment that can be confidently released to the public. There are many factors that are beyond the control of American Gene™ (and even the FDA) that may cause delays, but they are all important to consider in advancing medicine.