Mexico / Chile / Turkey / Russia / United States / Brazil / China / Argentina / Spain / /
Event
FDA Phase / Business Partnership / /
Facility
Long Island Center laboratory / Emory University Hospital / DG facility / Westchester Medical Center / S.A. facility / /
IndustryTerm
column agglutination technology / accessory equipment / information technology systems / operational and monitoring systems / material management systems / laboratory control systems / in vitro substance / shared and dedicated equipment / plastics / final product / operators/site / test site / pharmaceutical grade water / in vitro product / manufacturing / individual site / lot release protocol / /
Organization
New York Blood Center / Division of Blood Applications / office of Blood Research and Review Applicant Name / office of Compliance / Food and Drug Administration Center for Biologics Evaluation and Research From / MEMORANDUM Department of Health / Westchester Medical Center / NT TP / office of Blood Research / Indiana Blood Center / Office Signatory Authority / Emory University Hospital / FDA / Department of Health and Human Services / Gulf Coast Regional Blood Center / /
Person
Paul Hshieh Review Memo / Priscilla Pastrana / Joyce Rockwell Review Memo / Joyce Rockwell Review Memos / Dana Martin Review Memo / Mary Malarkey / Joyce Rockwell / Lot Release / Catherine Poole Review Memos / Jay Epstein / /
Position
Director / CBER / technologist / Director / Consumer Safety Officer / Devices Review Branch / /
Product
IgG 8 IgG IgG The / DG Gel® / DG / DG Gel / Anti-Human Globulin / /
MEMORANDUM Department of Health and Human Services Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research