CBER Approvals Hit A High Note For Director Midthun's Swan Song

Twelve novel biologics in 2015 sets record, with 'biobetter' coagulation factors again making up largest group of new products.

Novel approvals from FDA's Center for Biologics Evaluation and Research grew for a fourth consecutive year in 2015, sending off retiring center director Karen Midthun with a record high count of 12 new biologics.

While CBER has at times been known for rocky review performance, consistent gains over the last three years suggest that...

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