1. Guidance for Industry. Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009.
2. Draft Guidance for Industry and FDA Staff. Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. October 20, 2009
3. A Proposed Approach to Regulation of Cellular and Tissue-Based Products (62 FR 9721, March 4, 1997).
4. 21 CFR 1271.
5. Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (66 FR 5447), January 19, 2001.