Sipuleucel-T Trade / Dendreon Corporation / Laboratory Information Management Systems / sipuleucel-T (Provenge®) Dendreon Corporation / /
Event
Product Issues / /
Facility
QC laboratory / NJ facility / New Jersey facility / /
Holiday
between Day / /
IndustryTerm
cGMP manufacturing area / manufacturing facility / manufacturing incidents / final product / manufacturing module / data showing that product / infusion site / adequate product / manufacturing logitics / manufacturing steps / leukapheresis product / manufacturing sites / overall manufacturing schedule / manufacturing site / manufacturing / sample management / autologous product / clinical product / manufacturing process / concurrent manufacturing / /
MedicalCondition
sterility / alternative sterility / prostate cancer / /
MedicalTreatment
leukapheresis / apheresis / immunotherapy / /
Organization
New Jersey District Office / International Monetary Fund / office of Regulatory Affairs / CBER / FDA / Cell and Gene Therapies office of Cellular / Tissue / and Gene Therapies Reviewed / /
Person
Malcolm Moos / Morris Plains / Thomas Finn / Keith Wonnacott / Steven Oh / Syed Husain / Raj Puri / Kimberly Benton / Gene Therapies / /
Position
Director / Division / Director / Deputy Division / Branch Chief / EXECUTIVE / representative / analyst / Deputy Division Director / Director Division / /
BLA[removed]Resubmission CMC Review of Complete Response Letter Items (Including 483 items) and Additional Information Not Contained in Original Submission - Provenge