"Breakthrough" The Barriers: Breakthrough Therapy Designation For 505(b)(2)

By Lisa Crose, PhD, Scientific and Regulatory Specialist, and Angela Drew, PhD, Product Ideation Consultant

Breakthrough Therapy Designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. In comparison to Fast Track Designation (discussed in a prior blog), the qualifying criteria for BTD are more stringent. However, if granted, BTD provides significant Agency commitment and guidance, leading to a more efficient development program and faster time to market. As described below, 505(b)(2) products can and have been approved with BTD.