FDA Guidance, Cellular Therapy for Cardiac Disease.
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The FDA, are issuing this guidance to provide you, sponsors who are developing cellular therapies for the treatment of cardiac disease, with recommendations on the design of preclinical and clinical studies, and on the chemistry, manufacturing, and controls (CMC) information to include in an Investigational New Drug application (IND) for cellular theracardiac disease. This guidance also provides recommendations regarding the information thyou should submit on the product’s delivery system. Sponsors should consult with FDA concerning the regulatory pathway for the use of cell selection devices.
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