CBER Goes Above and Beyond PDUFA Goals in 2012, Completing All BLA Reviews on Time

December 27, 2012
CBER completed 100 percent of standard and priority BLA reviews within specified timeframes during fiscal 2012, exceeding the goals of the Prescription Drug User Fee Act (PDUFA). The fourth iteration of PDUFA required CBER to act on 90 percent of standard BLAs within 10 months of receipt, and 90 percent of priority reviews within six months.
Drug Industry Daily