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Food and Drug Administration / Pharmacology / Therapeutics / United States Public Health Service / Medicine / Pharmaceutical sciences / Clinical research / Clinical pharmacology


Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting December 11, 2014 Location: FDA White Oak Camp
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Company

Nektar Therapeutics / SPONSOR PRESENTATIONS Synta Pharmaceuticals Corp. / Synta Pharmaceuticals Corp. / ADP / HOFFMAN-LA ROCHE INC. / GANETESPIB - SYNTA PHARMACEUTICALS CORP. / PhD Chief Medical Officer Synta Pharmaceuticals Corp. / Hoffmann-La Roche Inc. / MD Acting / /

Facility

FDA White Oak Campus / White Oak Conference Center / /

IndustryTerm

potential administration protocols / treatment of some pediatric cancers / administration protocols / /

MedicalCondition

pediatric tumors / adult cancer / intact p53 tumor / solid tumors / neuroblastoma / Specific tumors / e.g. neuroblastoma / liver tumors / diarrhea / MS / brain tumors / specific diseases / tumor / specific pediatric solid tumors / relapsed neuroblastomas / tumors / disease / solid tumor / severe diarrhea / different solid tumors / bone tumors / sarcoma / diseases / sarcomas / pediatric cancers / anaplastic lymphoma kinase / acute myeloid leukemia / acute leukemias / /

MedicalTreatment

antibiotics / /

Organization

Oncology Subcommittee / office of Hematology and Oncology Products / office of New Drugs / Food and Drug Administration / Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes / George Washington School / FDA / Oncologic Drugs Advisory Committee / Information Office / Center for Drug Evaluation and Research / Pediatric Oncology Subcommittee / /

Person

Bernard F. Cole / Bruce J. Roth / Pediatric Oncology / Howard Fingert / Carlos Rodriguez-Galindo / Alison Hannah / Caleb D. Briggs / Vojo Vukovic / Alberto Pappo / Tito Fojo / Kim / Leo Mascarenhas / Beverly Lange / Julia Glade Bender / Introductory Remarks Gregory Reaman / Ira Dunkel / Malcolm Smith / Carola Arndt / James Liebmann / Gregory Reaman / Michael Menefee / Jane Zones / Louis F. Diehl / Carlo Di Fonzo / Amy Barone / Richard Pazdur / Aman Buzdar / Harold J. Burstein / Denise Casey / ODAC FDA / Nancy Goodman / Kathleen Neville / Leigh Marcus / Deborah K. Armstrong / Richard Gorlick / /

Position

investigator / Consultant / Director for Oncology Sciences Division of Hematology Products / Site Head / Vice President Drug Development / Federal Officer / Professor of Pediatrics / Chairperson / Representative / Designated Federal Officer / PharmD Designated Federal Officer / /

Product

Etirinotecan / application / Nektar Therapeutics Etirinotecan Pegol / Etirinotecan / /

ProvinceOrState

Maryland / /

Technology

potential administration protocols / Pharmacokinetics / administration protocols / Drug Development / /

URL

http /

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