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Pediatric Study Progress1 The following table provides statistics on the progress of studies with a due date of September 27, 2007, or later. Many of these studies are from deferrals granted prior
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CDER pediatric study progress refers to the ongoing assessment of pediatric clinical trials conducted by the Center for Drug Evaluation and Research.
Sponsors conducting pediatric clinical trials are required to file CDER pediatric study progress reports.
CDER pediatric study progress reports can be filled out online through the FDA's Electronic Submissions Gateway (ESG).
The purpose of CDER pediatric study progress reports is to monitor the safety and efficacy of drugs in pediatric populations and ensure compliance with pediatric study requirements.
CDER pediatric study progress reports must include information on the progress of pediatric clinical trials, any adverse events, changes in study protocols, and updates on patient recruitment.
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