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Zdrowie i gospodarka · 4.11.2010

Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Cellular Therapy for Cardiac Disease" dated October 2010. The guidance document provides 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 that should be included in an investigational new drug application (IND) for cellular therapy for cardiac disease. The guidance announced in this notice finalizes the draft guidance entitled "Guidance for Industry: Somatic Cell Therapy for Cardiac Disease" dated March 2009.

Source: Federal Register — Health and Human ServicesOpen original release →