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FDA Achieves Historically Low Eight-Month Median Drug Review Time In 2017

 
• By Michael Cipriano

Median review times for US agency's drug center were 10 months from 2011 to 2013, and 11 months from 2015 to 2016.

FDA entrance sign 2016

On top of setting a new record in the number of new drugs approved in 2017, the US FDA's Center for Drug Evaluation and Research (CDER) also appears to have achieved a historic low in terms of median review time of approved products, which clocked in at eight months for the year.

Using an arithmetic mean, CDER's average review time – calculated from the date of FDA’s receipt of the original application to the date of approval – for new drugs in 2017 was slightly higher than that of 2016

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