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1995 Priority Review of BLAs resulted in 2 approvals with a median total approval time of 50.37 months.
1995 Standard Review of BLAs resulted in 16 approvals with a median total approval time of 34.42 months.
1995 Blood Banking Review of BLAs resulted in 11 approvals with a median total approval time of 10.13 months.
1995 Review of PMAs resulted in 0 approvals.
1995 Review of 510ks resulted in 51 approvals with a median total approval time of 6.7 months.
1996 Priority Review of BLAs resulted in 3 approvals with a median total approval time of 11.87 months.
1996 Standard Review of BLAs resulted in 24 approvals with a median total approval time of 39.63 months.
1996 Blood Banking Review of BLAs resulted in 10 approvals with a median total approval time of 10.18 months.
1996 Review of PMAs resulted in 3 approvals with a median total approval time of 11.7 months.
1996 Review of 510ks resulted in 31 approvals with a median total approval time of 5 months.
1997 Priority Review of BLAs resulted in 7 approvals with a median total approval time of 8.94 months.
1997 Standard Review of BLAs resulted in 22 approvals with a median total approval time of 22.07 months.
1997 Blood Banking Review of BLAs resulted in 8 approvals with a median total approval time of 10.99 months.
1997 Review of PMAs resulted in 0 approvals.
1997 Review of 510ks resulted in 46 approvals with a median total approval time of 11.1 months.
1998 Priority Review of BLAs resulted in 8 approvals with a median total approval time of 6.91 months.
1998 Standard Review of BLAs resulted in 13 approvals with a median total approval time of 23.42 months.
1998 Blood Banking Review of BLAs resulted in 6 approvals with a median total approval time of 11.94 months.
1998 Review of PMAs resulted in 0 approvals.
1998 Review of 510ks resulted in 52 approvals with a median total approval time of 15.1 months.
1999 Priority Review of BLAs resulted in 3 approvals with a median total approval time of 13.87 months.
1999 Standard Review of BLAs resulted in 4 approvals with a median total approval time of 24.18 months.
1999 Blood Banking Review of BLAs resulted in 3 approvals with a median total approval time of 8.32 months.
1999 Review of PMAs resulted in 2 approvals with a median total approval time of 24.7 months.
1999 Review of 510ks resulted in 44 approvals with a median total approval time of 7 months.
2000 Priority Review of BLAs resulted in 1 approvals with a median total approval time of 8.52 months.
2000 Standard Review of BLAs resulted in 9 approvals with a median total approval time of 28.67 months.
2000 Blood Banking Review of BLAs resulted in 2 approvals with a median total approval time of 16.80 months.
2000 Review of PMAs resulted in 0 approvals.
2000 Review of 510ks resulted in 22 approvals with a median total approval time of 3.3 months.
2001 Priority Review of BLAs resulted in 2 approvals with a median total approval time of 13.18 months.
2001 Standard Review of BLAs resulted in 8 approvals with a median total approval time of 23.74 months.
2001 Blood Banking Review of BLAs resulted in 5 approvals with a median total approval time of 16.63 months.
2001 Review of PMAs resulted in 3 approvals with a median total approval time of 10.5 months.
2001 Review of 510ks resulted in 25 approvals with a median total approval time of 5.5 months.
2002 Priority Review of BLAs resulted in 6 approvals with a median total approval time of 14.69 months.
2002 Standard Review of BLAs resulted in 10 approvals with a median total approval time of 19.91 months.
2002 Blood Banking Review of BLAs resulted in 4 approvals with a median total approval time of 10.61 months.
2002 Review of PMAs resulted in 2 approvals with a median total approval time of 19.9 months.
2002 Review of 510ks resulted in 42 approvals with a median total approval time of 6.2 months.
2003 Priority Review of BLAs resulted in 5 approvals with a median total approval time of 22.18 months.
2003 Standard Review of BLAs resulted in 11 approvals with a median total approval time of 30 months.
2003 Blood Banking Review of BLAs resulted in 6 approvals with a median total approval time of 8.66 months.
2003 Review of PMAs resulted in 3 approvals with a median total approval time of 8.5 months.
2003 Review of 510ks resulted in 47 approvals with a median total approval time of 2.3 months.
2004 Priority Review of BLAs resulted in 0 approvals.
2004 Standard Review of BLAs resulted in 2 approvals with a median total approval time of 19.77 months.
2004 Blood Banking Review of BLAs resulted in 2 approvals with a median total approval time of 12.91 months.
2004 Review of PMAs resulted in 1 approvals with a median total approval time of 5.9 months.
2004 Review of 510ks resulted in 62 approvals with a median total approval time of 2.5 months.
Beginning in 2004, these figures exclude BLAs for therapeutic biologic products transferred from CBER to CDER effective 10/1/2003.