Guidance : Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Process Validation : General Principles and Practices (applicable to “351” HCT/Ps)
Draft Guidance : Somatic Cell Therapy for Cardiac Disease
Draft Guidance : Potency Tests for Cellular and Gene Therapy Products
Draft Guidance : Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products
Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconsitution for Specified Indications.