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FDA Briefing Document Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) November 5, 2013 DISCLAIMER STATEMENT The attached package contains background information prepared by the Food and D
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Company

Merck / Bristol Myers Squibb Co. / Novartis Pharmaceuticals Corporation / FDA Briefing Document Page 4 Best Pharmaceuticals / Nivolumab COMPANY / /

Event

FDA Phase / /

IndustryTerm

biological products / treatment of unresectable or metastatic melanoma / products / therapies for pediatric rare diseases / biologic products / chemical and physical agents / treatment of pediatric cancer / /

MedicalCondition

tumor / rare diseases / pediatric cancer / cancer / tumors / disease / original rare disease / rhabdomyosarcoma and other tumor / rare disease / osteosarcoma / neuroblastoma / childhood cancer / rare pediatric disease / factors influencing tumor / sarcoma / melanoma / Therefore pediatric tumors / pediatric tumor / non-small cell lung cancer / adult cancers / pediatric cancers / selected pediatric tumor / cell carcinoma / pediatric rare disease / recurrent solid tumors / pediatric rare diseases / refractory malignant solid tumor / metastatic melanoma / rhabdomyosarcoma / /

MedicalTreatment

immunotherapies / chemotherapy / /

Organization

Congress / Oncology Subcommittee / office of Hematology and Oncology Products / Food and Drug Administration / Review Division / DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring / Oncologic Drugs Advisory Committee / FDA Briefing Document Pediatric Oncology Subcommittee / Advisory Committee / Pediatric Oncology Subcommittee / /

Person

Summaries Morning / Richard Pazdur / /

Position

Director / Executive / /

Product

Act / MK3475 / CA209070 / /

ProvinceOrState

Maryland / /

Technology

chemotherapy / drug development / /

URL

http /

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