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Pneumococcal conjugate vaccine / Biology / Microbiology / Pneumococcal polysaccharide vaccine / Pneumococcal vaccine / Vaccines / Pneumonia / Medicine


Summary Basis for Regulatory Action Date: February 22, 2010 From: Julienne Vaillancourt, R.Ph., M.P.H., Review Committee Chair
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Company

CMC Commitments Lots / Pfizer Inc. / Regulatory History Wyeth Pharmaceuticals Inc. / Wyeth Pharmaceuticals Inc. / Wyeth / /

Continent

North America / /

Country

United States / Finland / /

Event

M&A / Person Communication and Meetings / FDA Phase / /

IndustryTerm

final drug product / manufacturing activities / healthcare system / prevention of invasive disease / manufacturing consistency / acute otitis media / owned subsidiary / gas chromatography / prevention of invasive pneumococcal disease / manufacturing facilities / rubber / antigen antigen antigen antigen antigen antigen carrier protein / clinical and physico-chemical criteria / otitis media / product manufacturing / manufacturing process / stability protocols / /

MedicalCondition

invasive disease / sterility / acute otitis media / invasive pneumococcal disease / otitis media / non-toxic diphtheria CRM197 / /

MedicalTreatment

active immunization / /

MusicGroup

Ph.D. / /

Organization

Division of Product Quality / Vaccines Research and Review Office’s Signatory Authority / Vaccine and Related Biological Products Advisory Committee / Review Committee / FDA / office of Vaccines Research / /

Person

Eugenia Dragunsky / John Cipollo / Labeling Manju Joshi James Kenney / Wellington Sun / Jingyee Kou / Julienne Vaillancourt / Drusilla Burns / Tina Khoie / Memo Marthe Bryant / Lot Release Release Testing / Catherine Miller Solomon Yimam / Mustafa Akkoyunlu / P.H. Douglas Pratt / Alfred Del Grosso / Lev Sirota / Norman W. Baylor / Michael Schmitt / Rajesh Gupta / Nancy Waites / Claudia Wrzesinski / /

Position

Director / Chair / /

Product

Prevnar 13 / Conjugate Vaccine / /

Region

Northern California / /

Technology

Spectroscopy / gas chromatography / stability protocols / pdf / /

URL

http /

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