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The 505(b)(2) Development Pathway

Reducing time and cost to market

The 505(b)(2) New Drug Application (NDA) pathway is a unique regulatory pathway that often reduces the clinical program for a new drug product – accelerating drug approval and allowing sponsors to obtain marketing exclusivity and patent protection. This expedited pathway can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.

Development of a 505(b)(2) drug product requires careful understanding of the regulatory pathway and strategic input into designing appropriate pharmacokinetic bridging, nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) programs that will meet applicable regulatory requirements. Thus, 505(b)(2) drug development requires a holistic, team-based approach with extensive interaction. Learn more about the benefits of the 505(b)(2) Pathway. 

NonClinical and 505(b)(2) CMC and 505(b)(2) Clinical PK and 505(b)(2) Regulatory and 505(b)(2)