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Health / Pharmacology / Food and Drug Administration / Cervarix / HPV vaccine / Center for Biologics Evaluation and Research / Human papillomavirus / AS04 / GlaxoSmithKline / Medicine / Papillomavirus / Vaccines


Discussion of Complete Response Letter Safety Items - Cervarix, January 16, 2008
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Company

GlaxoSmithKline Biologicals / CBER / GSK / /

Country

United States / /

Event

M&A / FDA Phase / Business Partnership / /

IndustryTerm

treatment / firewall / /

MedicalCondition

hydatidiform mole / HPV / spontaneous abortions / ectopic pregnancies / spontaneous abortion / /

MedicalTreatment

vaccination / /

Organization

FDA / /

Person

Helen S. Gemignani / Whitman / /

/

Position

investigator / Manager Discussion / Official / Regulatory Project Manager / /

Product

Cervarix / HPV-008 / /

Technology

firewall / DLP / /

SocialTag