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Home » Approvals for 505(b)(2) Drugs Slower Than for NMEs, Report Says
Approvals for 505(b)(2) Drugs Slower Than for NMEs, Report Says
The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development.