Tuesday, August 31, 2021

New Spotlight on CDER Science on First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young

CDER researchers are engaging in the development of a first-of-kind pediatric ECG data warehouse that promises significant public health advances, including the elaboration of clinical guidelines for assessing risk in children, better pre- and post-market cardiac safety evaluation of drug products for children, and the development of biomarkers for use in pediatric clinical trials.

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