Zdrowie i gospodarka · 1/16/2009
Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)" dated January 2009. The draft guidance document provides establishments that manufacture HCT[sol]Ps with recommendations for complying with CGTP requirements.