U.S. Food and Drug Administration • Center for Drug Evaluation and Research
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Adverse Event Tracking as Mandated by the Best Pharmaceuticals for Children Act
Outline
Best Pharmaceuticals for Children Act (1/4/02)
Adverse Event Report Review Plan
Proposed Adverse Event Report Review Template
Proposed Adverse Event Report Review Template (cont’d)
Example of an Adverse Event Report
Preliminary Review of Adverse Event Report
Number of Adverse Event Reports by Age (2/1/02 to 12/5/02)
Most Frequently Reported Adult & Pediatric Adverse Events
Pediatric Adverse Events by Age and Gender (N=40 unduplicated)
Serious Outcomes in Pediatric Patients*
Clinical Conditions for Which Sertraline was Used
Review of Pediatric Deaths Case 1
Review of Pediatric Deaths Case 2
Review of Pediatric Deaths Case 3
Summary
Role of the Pediatric Advisory Subcommittee
Thank You
Author: Solomon Iyasu, M.D., M.P.H. Medical Team Leader Division of Pediatric Drug Development
Center for Drug Evaluation and Research Food and Drug Administration
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FDA/Center for Drug Evaluation and Research Last Updated: March 10, 2003 Originator: OD/OCTAP/DPDD HTML by MAU
