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Regulatory Focus™ > News Articles > Demystifying FDA’s 505(b)(2) Drug Registration Process

Demystifying FDA’s 505(b)(2) Drug Registration Process

Posted 01 October 2009

The US Food and Drug Administration's (FDA) legal/regulatory framework offers three pathways to approval of New Drug Applications (NDAs): 505(b)(1), 505(b)(2) and 505(j). This article provides an overview of the 505(b)(2) process in comparison to the other registration processes. In 2008, more than half of the new drugs approved in the US utilized the 505(b)(2) registration pathway. Of the 28 drug approvals in 2008 under this pathway, 50% were products with new formulations and the remainder were principally products with new molecular entities, changed active ingredients and new drug combinations. This reflects an increase from 2006 and 2007, for which the percentages were 20% and 43%, respectively.1


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