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Spotlight on CDER Science

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

The FDA utilizes an electrocardiogram (ECG) data warehouse to support the agency’s cardiac safety review of therapeutic product development programs. The ECG data warehouse allows the agency to review large volumes of ECG data collected from adult participants of clinical trials to detect abnormalities that may signal an increased risk for cardiac adverse events. Besides facilitating the storage of large amounts of data, the ECG data warehouse supports efforts to streamline and standardize the collection and curation of ECG raw data. To date, there is no equivalent pediatric ECG data warehouse to enhance cardiac safety review for therapeutic product development for children.

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