Pediatric Rule Update
for all applications
with new active ingredients, new dosage forms, new indications, new routes of
administration, and new dosing regimens
Quarterly Update
October 2002 - December 2002
|
Total
Number of Applications |
Waivers |
Full
Waivers |
Partial
Waivers |
Applications
with Deferred
Studies |
Applications
with Completed
Studies |
Applications
with Completed Studies not Associated with Peds Exclusivity |
Apr-Jun
2002 |
35 |
18 |
11 |
7 |
12 |
9 |
3 |
Jul-Sep
2002 |
37 |
23 |
10 |
13 |
8 |
12 |
4 |
Oct-Dec 2002 |
41 |
28 |
13 |
15 |
14 |
14 |
8 |
Total |
113 |
69 |
34 |
35 |
34 |
35 |
15 |
Cumulative Update
April 1999 - December 2002
|
Total
Number of Applications |
Waivers |
Full
Waivers |
Partial
Waivers |
Applications
with Deferred
Studies |
Applications
with Completed
Studies |
Applications
with Completed Studies not Associated with Peds Exclusivity |
Apr
1999 - Mar 2002 |
404 |
195 |
130 |
65 |
172 |
94 |
52 |
Apr
- Dec 2002 |
113 |
69 |
34 |
35 |
34 |
35 |
15 |
Total |
517 |
264 |
164 |
100 |
206 |
129 |
67 |
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FDA/Center for Drug Evaluation and Research
Last Updated: May 2, 2003
Originator: OCTAPP/DPDD
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