Inc. facility / Laboratory of Hemostasis/DH/OBRR Subject / GTC facility / /
IndustryTerm
final drug product / final drug products / process equipment / manufacturing runs / manufacturing steps / rAT processing / manufacturing facilities / physico-chemical and structural properties / proposed commercial manufacturing site / manufacturing / manufacturing milk pools / rAT final drug product / manufacturing process / /
MedicalCondition
hereditary deficiency / congenital AT deficiency / diseases / /
MedicalTreatment
intravenous infusion / /
Organization
Review Committee / Department of Health and Human Services / MEMORANDUM Department of Health / Food and Drug Administration Center for Biologics Evaluation and Research To / Laboratory of Hemostasis/DH/OBRR Subject / /
Person
Timothy Lee / Iftekhar Mahmood / Chiang Syin / Philip Snoy / Paul Hsieh (Biostatistics) / Roman Drews / Joseph Manik / Maryann Gallagher / Faith Barash (Epidemiology) / Evi Struble / Nisha Jain / /
Approval of Biologics License Application from GTC Biotherapeutics, Inc. for Antithrombin