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.
You may also be interested in...
The latest drug development news and highlights from our FDA Performance Tracker.
While CBER is often perceived to be as much focused on research as it is on application review, Midthun was central to many key policy debates.
Both FDA’s biologics and drug centers posted historic BLA approval counts in 2014, combining to clear 21 novel biologics. The class is split between medical breakthroughs and “biobetters” offering incremental improvements, illustrating the maturation of the biotech industry.