What Goes Up … US FDA Expects 2016 NME Approval Total To Come Down

After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again.

FDA's approval metrics could not remain at record levels forever, and it now appears the regression toward the mean has begun.

Office of New Drugs Director John Jenkins said approvals in 2016 are down from last year, in part because the...

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