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Blood / Anatomy / Factor VIII / Coagulation / Biologic / Haemophilia / Etanercept / Moroctocog alfa / Fusion protein / Biology / Coagulation system / Recombinant proteins


Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM Date:
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City

Bristol / Josephson / /

Company

AEs / vWD / Amgen / Biogen Idec / Pfizer / Astellas Pharma / Wyeth / Novo Nordisk / Regeneron Pharmaceuticals / /

Continent

Europe / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

recombinant antihemophilic product / treatment of inflammatory diseases / pharmaceutical / manufacturing / perioperative management / treatment of hemophilia / /

MedicalCondition

photophobia / hemophilia A. Fusion / HIV / headache / Haemophilia / rheumatoid arthritis / thrombocytopenia / infectious / psoriasis / infections / Hemophilia / hemophilia A / chronic / Hemophilia B / hematologic malignancies / diseases / HIV/AIDS / infection / thrombocytopenic purpura / acute myelogenous leukemia / hemophilia A. All / inflammatory / /

MedicalTreatment

surgery / /

Organization

Food and Drug Administration Center for Biologics Evaluation / Food and Drug Administration / Department of Health and Human Services / /

Person

Blood Safety Branch Michael Nguyen / Wambui Chege / Christopher Jankosky / /

Position

investigator / Acting Director / Division of Epidemiology Product / Officer / MPH Branch Chief / Medical Officer / Director / Division of Epidemiology Product / /

Product

Amevive / sodium chloride / FS / sterile water / Orencia / Enbrel / calcium chloride / Arcalyst / FVIII / FDA13 / IgG1 / 11Mar1966 / Table / 3082A1-301 / 3082A1-300 / /

ProvinceOrState

North Carolina / /

Technology

antibodies / pharmacokinetics / /

URL

http /

SocialTag