Article | October 9, 2023

Tapping Into The Unexplored Through 505(b)(2) Pathway

Source: Societalâ„¢ CDMO

By Jagjyot (Jot) Kaur, Market Intelligence Manager, Societal CDMO


Filing a drug through the 505(b)(2) regulatory pathway comes with substantial benefits. The enactment, enforced in 1984, allows applicants to use the existing safety and efficacy data of listed drugs to fast-track new drug entities to market. The Drug Price Competition and Patent Term Restoration (also known as the Hatch-Waxman Amendments) added sections 505(b)(2) and 505(j) to the FD&C Act creating new routes for obtaining approval for NDAs and ANDAs.

Like 505(b)(1), 505(b)(2) is an NDA that sidesteps the safety and efficacy assessments of a drug, cutting down the development time by years. Let’s review the three statutes that govern the approval pathways:

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