On The "Fast Track": Fast Track Designations For Your 505(b)(2) Drug Development Program

By Lisa Crose, PhD, Scientific and Regulatory Specialist

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite products where there is the greatest clinical need, the FDA offers four expedited programs to get beneficial therapies to patients faster: Priority Review, Accelerated Approval, Breakthrough Therapy Designation, and Fast Track Designation. In this blog, we will focus on the details of Fast Track Designation (FTD) and how 505(b)(2) products can qualify for this program.