Dendreon Corporation / Diosynth RTP Inc. / Corporate Scheduling Group / /
Country
United States / /
Event
Product Issues / FDA Phase / /
Facility
NJ facility / NJ plant / /
IndustryTerm
manufacturing facility / real-time product delivery / Manufacturing controls / infusion site / leukapheresis product / manufacturing sites / autologous product / treatment of symptomatic bone disease / contract manufacturing sites / licensed biological therapeutic drug products / manufacturing step times / manufacturing process / Contract manufacturing / final product / cellular product / prostate cancer therapy / manufacturing resources / contract manufacturer / strict chain / manufacturing quality / manufacturing / manufacturing site / historical manufacturing data / equipment systems / identical manufacturing process / /
MedicalCondition
primary prostate cancer / recurrent prostate cancer / Infectious agent testing / metastatic prostate cancer / established tumors / chronic toxicology / sterility / prostate-specific inflammation / metastatic disease / prostate cancer / resistant prostate cancer / Background Prostate cancer / murine EL4 lymphoma / tumor / Cancer / Endotoxin content Microbial contamination Sterility / symptomatic bone disease / disease progression requiring androgen deprivation therapy / bone metastases / inflammation / metastases / /
MedicalTreatment
salvage therapy / Immunization / leukapheresis / active immunotherapy / immunotherapy / radiation / cancer therapy / apheresis / /
Organization
Offices Signatory Authority / office of Compliance / QC Lab / FDA / /
Person
Barbara Wilimczyk / Guang Zhen / Malcolm Moos / Thomas Finn / Syed R Husain / T. Lot Release / Gang Wang / Bindu George / Gene Therapies Mary / Peter Bross / Wilson Bryan / Randa Melham / Celia Witten / Faith Barash / Keith Wonnacott / Steven Oh / Therapies Mary Malarkey / Catherine Miller / Lot Release / /
Position
prescribing physician / Director / Office / Director / Chair of the Review Committee / /
Summary Basis for Regulatory Action Template v 2