Biogen Idec Inc. / REVIEW SUMMARY Biogen Idec Inc. / 59 Biogen Idec Inc. / OCBQ/DMPQ / /
Event
FDA Phase / Reorganization / /
Facility
Biogen Idec facility / /
IndustryTerm
recombinant product / validation protocols / process validation protocols / treatment of hemophilia / reconstituted drug product / worst case equipment / manufacturing process / /
Organization
Compliance and Biologics Quality Division of Manufacturing / FDA / Biologics Evaluation and Research office of Compliance / HUMAN SERVICES Food and Drug Administration Center / DEPARTMENT OF HEALTH / /
Person
Nancy Kirschbaum / Ellen Huang / Marion Michaelis / /
Position
Director / OCBQ/DMPQ / Chair / Branch Chief / /
Product
HFM-380 / PPD-003246 / ALPROLIX™ / /
Technology
heat transfer / validation protocols / Recombinant DNA / /