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HPV vaccine / Gardasil / Cervarix / Human papillomavirus / Cervical cancer / Wart / Cervical intraepithelial neoplasia / Vaginal intraepithelial neoplasia / Genital wart / Papillomavirus / Medicine / Oncology


Food and Drug Administration Center for Biologics Evaluation and Research Office of Vaccines Research and Review Division of Vaccines and Related Product Applications Subject: Clinical Review of Biologics License Applic
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City

Related / /

Company

EGL / Merck / Luminex / M.D. / P.H Solomon Yimam Statistics / Applicant Merck Research Laboratories / /

Country

United States / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

prevention of the following diseases / prevention of high grade cervical disease / prevention of cervical cancer / prevention of cervical / vulvar and vaginal cancer / /

MedicalCondition

cancer / warts / disease / HPV / Cervical intraepithelial neoplasia / Genital warts / papillomavirus infections / persistent infection / diseases / CIN / infection / vaginal cancer / infections / cervical intraepithelial neoplasia competitive luminex immunoassay Page / /

MedicalTreatment

antibiotics / vaccination / /

Organization

Research office of Vaccines Research / Related Biological Products Advisory Committee / FDA’s Center for Biologics Evaluation and Research / Food and Drug Administration Center for Biologics Evaluation / Vaccines and Related Products Applications BLA Supplement Review Committee / Vaccines Research and Review Division of Vaccines and Related Product Applications Subject / Division of Vaccines and Related Products Applications To / office of Biostatistics and Epidemiology / FDA / Division of Vaccines and Related Products Applications Wellington / /

Person

Elizabeth Valenti / Old Women / Martha Lee / Lisa Stockbridge / Lewis Schrager / Solomon Yimam / Jeffrey N. Roberts / Jeff Roberts / /

Position

Manager Bioresearch Monitoring Reviewer Page / Director / Division / EXECUTIVE / Chairperson and Clinical Reviewer Labeling Reviewer Regulatory Project Manager / Major / Medical Officer / General / OFFICER / M. Chairperson and Clinical Reviewer Labeling Reviewer Regulatory Project Manager / Chief / /

Product

Sodium chloride / V501-019v1 / VLP Vaccine / BLA / BLA Supplement / Biologics License Application supplement / /

ProvinceOrState

Indiana / /

URL

http /

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