|
CDER Approval Times
for
Priority and Standard NDAs and 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 |
19 |
16.3 |
20.5 |
51 |
20.8 |
26.9 |
|
1994 |
16 |
13.9 |
14.0 |
45 |
16.8 |
21.0 |
|
1995 |
16 |
7.9 |
7.9 |
67 |
16.2 |
18.7 |
|
1996 |
29 |
7.8 |
7.8 |
102 |
15.1 |
17.8 |
|
1997 |
20 |
6.3 |
6.4 |
101 |
14.7 |
15.0 |
|
1998 |
25 |
6.2 |
6.4 |
65 |
12.0 |
12.0 |
|
1999 |
28 |
6.1 |
6.1 |
55 |
12.0 |
13.8 |
|
2000 |
20 |
6.0 |
6.0 |
78 |
12.0 |
12.0 |
|
2001 |
10 |
6.0 |
6.0 |
56 |
12.0 |
14.0 |
|
2002 |
11 |
13.8 |
19.1 |
67 |
12.7 |
15.3 |
|
2003 |
14 |
7.7 |
7.7 |
58 |
11.9 |
15.4 |
|
2004* |
29 |
6.0 |
6.0 |
90 |
11.9 |
12.9 |
|
2005* |
22 |
6.0 |
6.0 |
58 |
11.8 |
13.1 |
|
2006* |
21 |
6.0 |
6.0 |
80 |
12.0 |
13.0 |
* 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 |
