|
CDER Approval Times
for
Priority and Standard NMEs and New BLAs
Calendar Years 1993 - 2006*
|
Calendar
Year |
Priority |
Standard |
Number Approved |
Median FDA Review Time (months |
Median Total Approval Time (months) |
Number Approved |
Median FDA Review Time (months) |
Median Total Approval Time (months) |
|
1993 |
13 |
13.9 |
14.9 |
12 |
27.2 |
27.2 |
|
1994 |
12 |
13.9 |
14.0 |
9 |
22.2 |
23.7 |
|
1995 |
10 |
7.9 |
7.9 |
19 |
15.9 |
17.8 |
|
1996 |
18 |
7.7 |
9.6 |
35 |
14.6 |
15.1 |
|
1997 |
9 |
6.4 |
6.7 |
30 |
14.4 |
15.0 |
|
1998 |
16 |
6.2 |
6.2 |
14 |
12.3 |
13.4 |
|
1999 |
19 |
6.3 |
6.9 |
16 |
14.0 |
16.3 |
|
2000 |
9 |
6.0 |
6.0 |
18 |
15.4 |
19.9 |
|
2001 |
7 |
6.0 |
6.0 |
17 |
15.7 |
19.0 |
|
2002 |
7 |
13.8 |
16.3 |
10 |
12.5 |
15.9 |
|
2003 |
9 |
6.7 |
6.7 |
12 |
13.8 |
23.1 |
|
2004* |
21 |
6.0 |
6.0 |
15 |
16.0 |
24.7 |
|
2005* |
15 |
6.0 |
6.0 |
5 |
15.8 |
23.0 |
|
2006* |
10 |
6.0 |
6.0 |
12 |
12.5 |
13.7 |
* Beginning in 2004, these figures include new BLAs for
therapeutic biologic products transferred from CBER to CDER.
updated through
12/31/2006
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Date created: January 29, 2007 |
