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As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012.
In addition, the Center for Biologics Evaluation and Research (CBER) approved eight novel products, including innovative influenza vaccines and a number of blood products.
The lower approval total, FDA officials have emphasized in recent weeks, fit the averages of the last ten years and is not a sign of decreased innovation by manufacturers or any slowdown in the agency’s approval process. John Jenkins, director of CDER’s Office of New Drugs, explained at a December meeting that the main reason for the decline in approvals last year is a drop in the number of new drug applications filed with the agency, and not more rejections by FDA. CDER met review time frames for all of the new NMEs, and most of them (89%) were reviewed in the first review cycle.
A report from CDER on the 2013 new drug approvals [available at www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm]