| Open Document File Size: 1,40 MBShare Result on FacebookCompany Merck & Co. Inc. / Merck / Luminex / Sentinel / Designated (Yes/No) Merck Sharp & Dohme Corp. / Laboratories Merck Sharp & Dohme Corp. / Applicant Merck & Co. / / Country United States / / Currency USD / / Event FDA Phase / / IndustryTerm treatment of cervical cancer / injection site / prevention of the following diseases / manufacturing / qHPV vaccine / / MedicalCondition vaginal cancers / cervical cancers / Papillomavirus (HPV) infection / cancers / common cancer / anal cancer / benign and malignant dysplastic disease / cancer / Disease / warts / HPV / Cervical cancer / potential autoimmune disorders / erythema / Cervical intraepithelial neoplasia / Genital warts / spontaneous abortions / anal cancers / Chronic HPV infection / persistent infection / diseases / multiple sclerosis / CIN / anal disease / infection / MS / anogential cancers / intraepithelial neoplasia Adenocarcinoma / spontaneous abortion / cervical and other anogenital cancers / adenocarcinoma / / MedicalTreatment contraception / vaccination / / Organization Food and Drug Administration / Date PDUFA Goal Date Division / FDA / / Person ELISA FAS FDA GCP / Sixun Yang / Doran Fink / Andrea Hulse / Nancy Miller / / Position Team Leader / / Product chorionic gonadotropin / Intramuscular Injection / Prophylactic Vaccine Sterile suspension / Quadrivalent Human Papillomavirus vaccine / qHPV / / ProvinceOrState Mississippi / / PublishedMedium the Clinical Review / / Technology antibodies / Interactive Voice Response System / /
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Clinical Reviewer: Sixun Yang, MD, PhD STN: [removed]Application Type STN CBER Received Date