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Stem cells / Transplantation medicine / Childbirth / Graft-versus-host disease / Cord blood bank / Hematopoietic stem cell transplantation / Cord blood / National Marrow Donor Program / CD34 / Biology / Medicine / Health


BLA STNs# [removed] &[removed]I concur with this review. M. Serabian[removed]; re-concurred on[removed]FOOD AND DRUG ADMINISTRATION Center for Biologics Evaluation and Research Office of Cellular, Tissue and Gene Ther
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City

Milano / Dusseldorf / /

Company

New York Blood Center / Cox / /

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Event

Reorganization / FDA Phase / /

Facility

New York Blood Center / Duke University / RAC Duke Translational Medicine Institute Hock Plaza / Building Durham / Duke University Medical Center / /

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IndustryTerm

post-processing viability / blood products / biological product / cellular biologic product / final product / /

MedicalCondition

Hurler Syndrome / JE / Krabbe Disease / chronic toxicology / hematological malignancies / primary immunodeficiency diseases / peroxisomal enzyme deficiency disorders / hematologic disorders / tailbud deformities / Infantile Krabbe’s Disease / immune deficiency / Thalassemia / metabolic disorders / anencephalia / hemoglobinopathies / thalassemia PHARM/TOX REVIEWER / Globoid Leukodystrophy / disease / malignant and nonmalignant diseases / diseases / exencephaly / sickle cell disease / inborn errors of metabolism / Hurler’s Syndrome / X-linked Adrenoleukodystrophy / anencephaly / storage disorders / /

MedicalTreatment

chemotherapy / /

Organization

Research office of Cellular / Gene Therapies Division of Clinical Evaluation and Pharmacology/Toxicology Pharmacology/Toxicology Branch / Center for International Blood and Marrow Transplantation Registry / FOOD AND DRUG ADMINISTRATION Center for Biologics Evaluation / Duke University School / Duke University / FDA / Firenze Blood Center / Duke University Medical Center / /

Person

D. Mercedes Serabian / Tissue Therapies / Cord Blood / Wilson Bryan / Celia Witten / Gene Therapies / Duke Translational / Bruce K. Burnett / Nancy C. Andrews / /

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Position

PROJECT MANAGER / Medicine Vice Chancellor for Academic Affairs / DIRECTOR DIVISION / Dean / author / PHARM/TOX SUPERVISOR / DIRECTOR OFFICE / /

Product

Sc / Citrate Phosphate Dextrose / Dextrose / dimethyl sulfoxide / this / /

RadioStation

CBU / /

Technology

ATM / transplantation / stem cells / pharmacokinetics / Biomaterials / chemotherapy / /

URL

http /

SocialTag