The primary goal of commercial drug development is approval by a regulatory agency, such as the Food and Drug Administration (FDA) in the U.S. Sponsors must submit a New Drug Application (NDA) for small-molecule drugs to reach market approval under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These applications must provide sufficient information for the Agency to determine whether the drug is safe and effective in the proposed indication before entering the market and becoming available for patient use.
To pursue marketing approval for NDAs, Sponsors must consider three primary types of regulatory pathways established under the FD&C Act Section 505. The pathways include 505(b)(1), 505(b)(2), and the 505(j).
In this whitepaper, our expert reviews top pathways and expands more specifically on the 505(b)(2) NDA Approval Pathway. If your program innovates products already on the market, there may be opportunities to conserve resources with insights outlined in this resource.
Written by Rohan Kantesaria, PharmD Candidate | Add Rohan on LinkedIn
Edited by Darius J. Devlin, PhD and Isaiah Manoogian, PharmD