The 505(b)(2) Development Pathway

The 505(b)(2) New Drug Application (NDA) regulatory pathway offers a unique opportunity for drug development; however, it comes without a preset playbook. With the right approach, this pathway can significantly reduce clinical program costs and expedite the time to approval, enabling sponsors to secure marketing exclusivity and patent protection. By minimizing expenses and accelerating the development process, sponsors can bring a new, differentiated product to market with substantial commercial potential.

Our Premier Consulting team has a deep understanding of the regulatory landscape and strategic insights into the design of pharmacokinetic bridging studies, nonclinical and clinical trials, and Chemistry, Manufacturing, and Controls (CMC) programs that align with regulatory expectations for 505(b)(2) products. Discover how our strategic team-based approach can support your success ensuring that your program meets all applicable regulatory requirements.