Regulatory Actions
Mortara Instrument Announces Extension of ECG Warehouse CRADA With US FDA
Published in Law and Health Weekly, December 6th, 2008
Today Mortara Instrument announced the extension of its Cooperative Research and Development Agreement (CRADA) with the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Under this extension, Mortara will continue to provide on-going development enhancements to the ECG Warehouse, which is used to store and review ECG submissions associated with new drug applications.
Mortara has a long-standing relationship with the FDA, providing ECG algorithm tools and data warehousing solutions to support the Agency's regulatory review of cardiac safety data. Since 2006, the FDA has been using the ECG Warehouse and toolset to review all Thorough QT...
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