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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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