In 1984 Hatch-Waxman Amendments created a much needed and streamline pathway for drug development. This approach known as 505 b(2) eliminates unnecessary duplication of research for the approval of a clinically significant improvement to a previously approved drug by allowing for the use of data not developed by the NDA applicant. This often leads to a faster route to approval when compared to traditional development pathways all the while creating new therapies that can benefit patients.
This combined with an Orphan Drug designation will help defer and lower the risks as well as can provide certain incentives such as: tax credits, grant funding, assistance for clinical research, and extended marketing exclusivity. Armed with initial clinical data which help tremendously by providong the foundational data set to present our development plan to regulatory authorities