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Blood / Transfusion medicine / Pharmaceutical industry / Pharmaceuticals policy / Clinical research / Validation / Plasmapheresis / Blood bank / Biologic License Application / Medicine / Food and Drug Administration / Health


Guidance on Blood and Blood for Transfusion of Further Manufacture
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City

Rockville / /

Company

IgG / Product Testing Laboratory / BACKGROUND Frequently / /

Country

United States / /

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Event

FDA Phase / /

Facility

FACILITY RELOCATIONS* / Component Preparation Facility / Hospital Blood Bank / Facility Changes / Collection Facility / Rockville Pike / /

IndustryTerm

ship excess products / comparability protocols / manufacturing changes / manufacturing step / blood products / web-based computer-assisted interactive interview software programs / change in its product / intermediate processing facility / manufacturing steps / apheresis products / fixed collection site / irradiated blood products / hospital blood bank / manufacturing / transfusion services / manufacturing practice / software program / storage services / non-profit blood collection/processing facility / licensed biological products / /

MedicalCondition

donor’s disease / certain diseases / communicable disease / /

MedicalTreatment

immunization / apheresis / plasmapheresis / /

Organization

office of Communication / Outreach and Development / Distribution Center / Food and Drug Administration / Center for Biologics Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center / office of Regulatory Affairs / Division of Dockets Management / Center for Biologics Evaluation and Research / Plasmapheresis Center / /

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Position

Official / Contractor / Governor / authorized official / /

Product

This / Special Labeling Supplement / labeling / Changes / Requiring / /

ProvinceOrState

Maryland / /

RadioStation

CBE / /

Technology

Comparability Protocol / antibodies / automated blood collection / comparability protocols / 23 COMPARABILITY PROTOCOL / /

URL

http /

SocialTag