Posted by Michael Wonder on 14 Sep 2016
FDA’s expedited programs and their impact on the availability of new therapies
7 September 2016 - The US FDA’s priority review, accelerated approval, fast track, and breakthrough therapy programs have been successful in facilitating the medicine approval process and improving access timelines.
A new paper by Damle et al. reviews the major guidelines set forth by the FDA, highlight advantages to the patient and health care community as a result of receiving specific designations, and provide several examples for illustration. As a result of these designations, many patients with rare diseases or life-threatening conditions have been afforded earlier access to effective therapies.
