Zdrowie i gospodarka · 2.04.2009
Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Somatic Cell Therapy for Cardiac Disease" dated March 2009. The draft guidance document provides sponsors of cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical and clinical studies, and information that should be submitted about the product delivery system. This guidance also provides recommendations on the chemistry, manufacturing and controls information to include in an investigational new drug application (IND) for cardiac cellular therapy.