Fresh from the biologic pipeline

Abstract

Though still underfunded and low on staff, the FDA managed to approve 21 new molecular entities (NMEs) in 2008, picking up momentum in the second half of the year and breaking a slide in approvals that had continued since the turn of the present century--except for the blip year 2004, when the agency's Center for Drug Evaluation and Research gave its blessing to 36 products. Included in 2008 approvals for NMEs were five new biologics, a slight uptick from 2007s 16 NMEs and two new biologics.