Clinical Studies Required For A 505(b)(2) Development Program

By Kevin Barber, Ph.D., RAC, PMP, Vice President, Regulatory Strategy & Submissions

A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program. In fact, in our experience, there’s a widespread misperception that “505(b)(2) NDAs require only one Phase 3 study”, and we’ve seen programs that have required more than one adequate and well-controlled (AWC) clinical study to gain approval.

The scope of clinical studies for a 505(b)(2) depends on the extent of the changes in the new drug product compared with the listed drug(s) (remember, as appropriate you can reference more than one listed drug).

Read real world scenerios to help gain a solid foundational understanding of the potential scope of clinical studies required as you embark on a 505(b)(2) development program is critical to move your new product forward to a timely submission of your marketing application.