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Food and Drug Administration / Food and Drug Administration Amendments Act / Food law / Drug safety / Biosimilar / New Drug Application / Pharmaceutical sciences / Pharmacology / Clinical research


FDA Briefing Document Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) November 1, 2011 DISCLAIMER STATEMENT
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Company

Sonic / GlaxoSmithKline / Adherex Technologies Inc. / Pazopanib COMPANY / MedImmune LLC / Genentech Inc. / Glaxo Wellcome Manufacturing Pte Ltd. / /

Country

Singapore / /

Event

FDA Phase / /

IndustryTerm

biological products / biological product / /

MedicalCondition

cancers / tumor / newly diagnosed cancer requiring intensive cisplatin therapy / cancer / tumors / disease / metastatic soft tissue sarcoma / soft tissue sarcoma / soft tissue sarcomas / osteosarcoma / neuroblastoma / sarcoma / advanced basal cell carcinoma / blocked medulloblastoma growth / standard risk hepatoblastoma / sarcomas / medulloblastoma / pediatric cancers / germ cell tumor / hepatoblastoma / hearing loss / advanced renal cell carcinoma / Rhabdomyosarcoma / pediatric solid tumors / /

MedicalTreatment

chemotherapy / cisplatin chemotherapy / surgery / /

Organization

American Speech-Language-Hearing Association / 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

Silver Spring / Richard Pazdur / /

Position

Director / /

Product

Cisplatin / sodium thiosulfate / ACCL0431 / UCM049870 / /

ProvinceOrState

Maryland / /

Technology

antibodies / chemotherapy / drug development / pdf / /

URL

http /

SocialTag