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AstraZeneca / Influenza A virus subtype H5N1 / Epidemiology / Vaccines / Center for Biologics Evaluation and Research / FluMist / MedImmune / AS03 / Medicine / Influenza / Health


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike
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Company

GlaxoSmithKline Biologicals / ID Biomedical Corporation / Glaxosmithkline plc / /

Event

FDA Phase / /

MedicalCondition

disease / influenza A / AS03 sterility / /

MedicalTreatment

active immunization / /

Organization

Food and Drug Administration / DEPARTMENT OF HEALTH / PMC/PMR Labeling Complete First Action Due Meetings First Committee / /

Person

Lien Lin / Elizabeth Sutkowski Elizabeth Sutkowski Lewis / Karen Campbell Manju Joshi Carmen / Jerry Weir Hana Golding David / Patricia Holobaugh Chiang Syin Chiang / Andrea James James Kenney Yes Yangdong Qiang / Elizabeth Sutkowski Lewis Schrager / Kirk Prutzman / William McCormick Laraine Henchal / Randa Melhem Carmen Collazo / Qiang Yes Andrea James Yes / Maryann Gallagher Cheryl Hulme / Elizabeth Sutkowski Erik Henchal William / Lewis Schrager Jerry Weir Hana / Karen Campbell / Nabil Al-Humadi / Lisa Stockbridge Joseph Quander III / Erik Henchal William McCormick Lewis / Randa Melhem Randa Melhem Lokesh / Manju Joshi / Qiang Hector Izurieta / Dale Horne Lisa Stockbridge Joseph / Anthony Hawkins / Robert D. Brobst / Wei Hua Richard Forshee Patricia Holobaugh Chiang / Hana Golding / Jeremy Wally / Karen Campbell James Kenney / Kirk Prutzman Kirk Prutzman / Lot Release / Randa Melhem Jei / Carmen Collazo / Elizabeth Sutkowski Elizabeth Sutkowski Elizabeth / Rajesh Gupta William McCormick William / Carmen Collazo-Custodio Jeremy / Carmen CollazoCustodio / William McCormick Lewis Schrager / Rajesh Gupta / Manju Joshi Lokesh Bhattacharyya / William McCormick William McCormick Laraine / William McCormick William McCormick William / Karen Campbell Karen Campbell James / Andrea James / Karen Campbell David Schwab / /

Position

Product Quality Electronic Integrity Review Supervisor / Chair / Chair The Chair / /

Product

AS03 / Virus Monovalent Vaccine / Pan-002 / /

ProvinceOrState

Quebec / Maryland / /

PublishedMedium

Milestones / /

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