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Article

Clinical Studies Required for a 505(b)(2) Development Program

Kevin Barber, Ph.D.

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.

Download this article to learn more about:

Factors that inform the scope of clinical studies for a 505(b)(2)
Scenario modeling and a real-world case example to illustrate common 505(b)(2) approaches for a clinical development program
Foundational elements of a 505(b)(2) development program that will help move your new product forward to a timely submission of your marketing application