CDER Priority NDA/BLA Approval Rates
for Applications Received FY 98 - 06 and Approved Within 36 Months
100
2001 2002
90
1998
80
2005
1999 2000 2003
70
2004
Percentage of Approvals
2006
60
50
40
1998 1999 2000 2001 2002 2003 2004 2005 2006
30
20
10
0 6 12 18 24 30 36 Approval Time In Six Month Intervals
• Beginning in 2004, these figures include BLAs for therapeutic biologic products transferred from CBER to CDER effective 10/1/2003. • Approvals through 31-Mar-07