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Biotechnology / Vaccines / Center for Biologics Evaluation and Research / Food and Drug Administration / Influenza / Influenza vaccine / Biologic / Vaccination / Flu pandemic / Medicine / Health / Biology


Summary Basis for Regulatory Action, January 16, [removed]Flublok
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City

McPherson / Meriden / /

Company

Background Protein Sciences Corporation / Protein Sciences Corporation / Hospira Inc. / /

Country

United States / /

Event

FDA Phase / /

Facility

CT facility / /

IndustryTerm

universal manufacturing process / trivalent final product / prevention of influenza illness / drug product / trivalent product / manufacturing process validation / degradation products / final filled product / baculovirus working virus bank / final product / contract manufacturer / aqueous buffered solution / manufacturing / trivalent drug product / manufacturing problems / /

MedicalCondition

egg-based influenza HA / whole influenza viruses / CDCprovided influenza virus / influenza-like illness / B influenza / influenza illness / influenza virus / influenza / inactivated / trivalent influenza / sore throat / influenza disease / seasonal influenza / trivalent inactivated influenza / coughing / trivalent influenza / each influenza / infection / /

MedicalTreatment

active immunization / vaccination / /

Organization

Approval Office Signatory Authority / office of Compliance / WCB / Centers for Disease Control and Prevention / MCB / Office Signatory Authority / MVB / FDA / WVB / Vaccines and Related Biological Products Advisory Committee / office of Vaccines Research / /

Person

Marion Gruber / Deborah Trout / Matthew Sandbulte / Barbara Krasnicka / Jean Makie / Patricia Rohan / Daphne Stewart / Maryann Gallagher / Maryna Eichelberger / Timothy Fritz / Review Cynthia Nolletti / Mary Malarkey / Karen Campbell / Kristina Carroll / Manju Joshi / Arifa Khan / Robert Wesley / Lot Release / Jane Woo / Lev Sirota / /

Position

Director / Chair / Committee / Chair Committee / /

Product

Sodium chloride / Flublok / influenza / /

ProvinceOrState

Kansas / Indiana / Connecticut / California / /

Technology

antibodies / /

SocialTag