FDA's Woodcock attributes 35 NME approvals to agency flexibility, creativity
This article was originally published in Scrip
In reporting that the US FDA has approved 35 new molecular entities (NMEs) in fiscal year 2011 – surpassed only in the past decade by FY 2009's count of 37 – Dr Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), came out swinging on 3 November, calling out statements from the drug industry that described the agency as not innovative "or that we make it too hard for companies to get a new product on the market".
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