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505(B) (2) Drug Development Pathway: A Within3 Whie Paper


The 505(b) (2) regulatory pathway is one of three categories of new drug applications (NDA). While the application requires full safety and effectiveness reports, it gives the FDA permission to use data not gathered by the NDA applicant, avoiding unnecessary duplicate analyses. Employing a 505(b) (2) regulatory strategy can offer significant benefits, encouraging innovation while offering a faster, more cost-efficient way to drug development.

According to the FDA, 45 novel drugs were approved as new molecular entities (NMEs) under NDAs or as new therapeutic biologics under Biologics License Applications (BLAs) in 2015. Of the novel drug approvals, 4 were approved through the 505(b) (2) pathway.


There are many advantages for developing drugs through the 505(b)(2) pathway, including Elimination of duplication, Reduction of risk and costs as well as Market exclusivity. A pre-investigational new drug (pre-IND) meeting can be very valuable in planning a 505(b)(2) application. The purpose of the pre-IND meeting is to review data from existing studies with the FDA and identify the gaps that are needed for NDA approval.

Pre-IND meetings can reduce time to market and help prevent issues from surfacing. As many components make up a successful application process, pharmaceutical companies must prepare for these pre-IND meetings. Within3’s virtual advisory board offers secure platform to foster compliant, open dialogue, examining all elements of the pre-IND meeting, from preparing a submission package to responding to FDA feedback.

Download '.pdf' Format of the whitepaper.

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