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Clinical pharmacology / Food and Drug Administration / Therapeutics / United States Public Health Service / Biosimilar / Off-label use / Food and Drug Administration Amendments Act / Moxifloxacin / Pharmacology / Pharmaceutical sciences / Clinical research


FDA Briefing Document Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) December 11, 2014 DISCLAIMER STATEMENT
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Company

Nektar Therapeutics / AEs / ALT/AST / FDA Briefing Document Page 4 Best Pharmaceuticals / Synta Pharmaceuticals Corporation / Hoffman-La Roche Inc. / Ganetespib COMPANY / Hoffmann-La Roche Inc. / /

Event

FDA Phase / /

IndustryTerm

biological products / products / therapies for pediatric rare diseases / biologic products / /

MedicalCondition

rare diseases / colorectal cancer / adult cancer / original rare disease / solid tumors / nausea / rare pediatric disease / hyponatremia / metastatic breast cancer / fatigue / diarrhea / pediatric rare disease / breast cancer / pediatric rare diseases / cancers / specific diseases / osteosarcoma / malignant peripheral nerve sheath tumor / peritoneal cancer / refractory sarcoma / cancer / MPNST / tumors / disease / neoplasm / NSCLC / hypophosphatemia / rare disease / severe diarrhea / sarcoma / vomiting / Therefore pediatric tumors / diseases / synovial sarcoma / increased ALT / anemia / rhabdomyosarcoma / /

MedicalTreatment

chemotherapy / /

Organization

Oncology Subcommittee / office of Hematology and Oncology Products / Food and Drug Administration / Congress / 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

investigator / physician / Director / Executive / /

Product

polyethylene glycol / Etirinotecan / application / 9 Morning Session PRODUCT /

ProvinceOrState

Maryland / /

Technology

chemotherapy / drug development / /

URL

http /

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