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Food and Drug Administration / Immunosuppressants / Amgen / Etanercept / Biologic / Center for Biologics Evaluation and Research / Rheumatoid arthritis / Validation / Biotechnology / Medicine / Pharmacology


DEPARTMENT OF HEALTH & HtJMAN
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City

Seattle / Rockville / /

Company

Irnmunex Corporation / FACP / Sally R. Gould Immunex Corporation / /

Event

Product Issues / /

Facility

packag&g facility / University Street Seattle / Bockville Pike / Rockville Pike / /

IndustryTerm

harvest media / proposed introductory advertising / Final printed advertising / drug product / contract distributor / portable stainless steel storage vessels / final formulated product / manufacturing facilities / unfiltered media / similar products / manufacturing operations / stability protocol / manufacturing process / licensed biological products / /

MedicalCondition

severely active rheumatoid arthritis / /

Organization

Food and Drug Administration / FACP Director office of Therapeutics Research / DEPARTMENT OF HEALTH / Center for Biologics Evaluation and Research / /

Person

Jay P. Siegel / /

Position

Director / representative / /

Product

Etanercept / Enbrel / Bacteriostatic Water for Injection / response / /

ProvinceOrState

Maryland / Washington / /

Technology

antibodies / stability protocol / /

SocialTag