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1995 Priority Review resulted in 16 approvals with a median total approval time of 7.9 months.
1995 Standard Review resulted in 67 approvals with a median total approval time of 18.7 months.
1996 Priority Review resulted in 29 approvals with a median total approval time of 7.8 months.
1996 Standard Review resulted in 102 approvals with a median total approval time of 17.8 months.
1997 Priority Review resulted in 20 approvals with a median total approval time of 6.4 months.
1997 Standard Review resulted in 101 approvals with a median total approval time of 15 months.
1998 Priority Review resulted in 25 approvals with a median total approval time of 6.4 months.
1998 Standard Review resulted in 65 approvals with a median total approval time of 12 months.
1999 Priority Review resulted in 28 approvals with a median total approval time of 6.1 months.
1999 Standard Review resulted in 55 approvals with a median total approval time of 13.8 months.
2000 Priority Review resulted in 20 approvals with a median total approval time of 6.0 months.
2000 Standard Review resulted in 78 approvals with a median total approval time of 12 months.
2001 Priority Review resulted in 10 approvals with a median total approval time of 6.0 months.
2001 Standard Review resulted in 56 approvals with a median total approval time of 14 months.
2002 Priority Review resulted in 11 approvals with a median total approval time of 19.1 months.
2002 Standard Review resulted in 67 approvals with a median total approval time of 15.3 months.
2003 Priority Review resulted in 14 approvals with a median total approval time of 7.7 months.
2003 Standard Review resulted in 58 approvals with a median total approval time of 15.4 months.
2004 Priority Review resulted in 29 approvals with a median total approval time of 6.0 months.
2004 Standard Review resulted in 90 approvals with a median total approval time of 12.9 months.
Beginning in 2004, these figures include BLAs for therapeutic biologic products transferred from CBER to CDER effective 10/1/2003.