The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / Division of Cell and Gene Therapy (DCGT), Office of Cellular, Tissue and Gene Therapy requires brand name or equal Human primary CD34+ hematopoietic stem and progenitor cells to have assessed identity and characterization of gene and cell therapy products to perform critical path research for its mission to develop and promote technology to regulate cellular and genetic therapeutics.
FDA-SSN-1233197 – Sources Sought – Human primary CD34+ Hematopoietic stem and Progenitor cells
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