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Clinical research / Pharmaceutical sciences / Center for Biologics Evaluation and Research / Medicine / Food and Drug Administration / Dendreon


DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality
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City

Morris Plains / /

Company

Dendreon / REVIEW SUMMARY Introduction Dendreon Corporation / /

Event

FDA Phase / /

Facility

QC laboratory / NJ facility / Facility Changes / /

IndustryTerm

software system / manufacturing facility / clinical manufacturing / manufacturing facility air system / lab equipment / software expert / manufacturing support areas / manufacturing / manufacturing batch record / manufacturing procedures / manufacturing processes / manufacturing process / /

MedicalCondition

independent prostate cancer / /

Organization

Food and Drug Administration Center for Biologics Evaluation / Research office of Compliance / Compliance and Biologics Quality Division of Manufacturing and Product Quality To / DEPARTMENT OF HEALTH / /

Person

Chiang Syin / Thomas Finn / Lori Tull / Gang Wang / /

Position

Microbiologist / Branch Chief / Biologist / /

Product

Provenge® / /

ProvinceOrState

New Jersey / /

Technology

process control / /

SocialTag