Article | June 6, 2022

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

Source: Premier Consulting

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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader