U.S. Food and Drug Administration • Center for Drug Evaluation and ResearchSkip navigation
CDER - Center for Drug Evaluation and Research Logo

Pediatrics

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

CDER ArchivesSpecific AudiencesCDER CalendarRegulatory InformationDrug InformationAbout CDERSide Navigational Buttons

Studies Breakdown Report
for Issued Written Requests
as of October 31, 2004

Pediatric Exclusivity

Type of Study

No.

%

Efficacy & Safety

242

35

PK & Safety

204

30

PK/PD

61

9

Safety

106

15

Other

72

11

Total

685

 
  • 685 studies requested/295 Written Requests issued
  • No. of studies which specified # of patients to be studied: 418
  • Projected total # of patients in requested studies: 42,905+

totop.gif (1525 bytes) Back to Top   Back Back to Pediatric Drug Development Page

FDA/Center for Drug Evaluation and Research
Last Updated: November 10, 2004
Originator: OCTAP/DPDD
HTML by MAU, RMJ