In 2007, there was much ado about the slow pace of new molecular entity (NME) approvals. Though over 200 drugs were approved in 2007, only 19Â of them represented groundbreaking advances in medicine.
In 2008, according to a post on Pharmalot, the industry is set to repeat last year's lackluster performance. Thus far the FDA has approved 14 NDAs but only one NME--the same rate of approval as last year. Why so slow? Analyst Jim Kumpel of Friedman Billings Ramsey says the FDA is hard at work implementing initiatives that resulted from PDUFA reauthorization. Others, including industry execs, are likely to blame the slowdown on a skittish post-Vioxx FDA that's suffered serious criticism for approving unsafe drugs.
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