FDA's proposed regulatory approach to regulation of hematopoietic stem/progenitor cell products.
Harvath
L
L
Laboratory of Cellular Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Division of Hematology, Rockville Pike, Bethesda, Maryland, USA.
D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D033161:Government Regulation; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D013048:Specimen Handling; D013234:Stem Cells / Q000166:cytology*; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
D011933:Reagent Kits, Diagnostic