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Biotechnology / Food and Drug Administration / Childbirth / Blood banks / Cord blood bank / Transplantation medicine / Cord blood / Current Good Tissue Practices / Center for Biologics Evaluation and Research / Biology / Medicine / Stem cells


Guidance for Industry Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications
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City

Rockville / /

Company

HPC-Cs / /

Country

United States / /

Event

FDA Phase / /

Facility

Document Control Center / Rockville Pike / /

IndustryTerm

biological products / to biologic products / cord blood bank / unrelated allogeneic hematopoietic stem/progenitor cell products / individual applications / manufacturing / unlicensed placental/umbilical cord stem/progenitor cell products / human cellular and tissue-based products / placental/umbilical cord blood products / cellular and tissue-based products / manufacturing process / allogeneic products / /

MedicalCondition

Hurler Syndrome / Globoid Leukodystrophy / Krabbe Disease / communicable diseases / Hematological Malignancies / Primary immunodeficiency diseases / peroxisomal enzyme deficiency disorders / diseases / Beta thalassemia / relevant communicable disease / /

Movie

D. VII / D. V / /

Organization

office of Communication / Outreach and Development / Biological Response Modifiers Advisory Committee / Food and Drug Administration / U.S. Department of Health and Human Services Food and Drug Administration Center / FDA / Public Health Service / Control Center / Center for Biologics Evaluation and Research / /

Person

Cord Blood Hematopoietic Stem / Cord Blood Intended / /

/

Position

Representative / General / /

Product

HPC-Cs / New Drug / /

ProvinceOrState

Maryland / Indiana / /

RadioStation

2 What / /

Technology

transplantation / /

URL

http /

SocialTag