The US FDA's popular 505(b)(2) new drug application pathway, a streamlined process most often used for new forms and formulations of existing drugs, does not produce shorter review times, an analysis by the Tufts Center for Drug Development and Sakai Regulatory Consulting found.
A Pathway, Not A Shortcut: 505(b)(2) NDAs Have Longer Reviews Than NMEs
US FDA's argument that its review resources favor novelty/medical advances could be buttressed by Tufts Center for the Study of Drug Development analysis of (less novel) approvals using the streamlined 505(b)(2) NDA pathway.
