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Clinical research / Biotechnology / Therapeutics / United States Public Health Service / Center for Drug Evaluation and Research / Biopharmaceutical / Biologic / Biosimilar / Oncology Drug Advisory Committee / Food and Drug Administration / Pharmacology / Pharmaceutical sciences


FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Meeting of the Oncologic Drugs Advisory Committee (ODAC) FDA White Oak Campus, Building 31, the Great Room (Rm[removed]White Oak Conference
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Company

Amgen Inc. / APPLICANT PRESENTATIONS Sandoz Inc. / Sandoz Inc. / PhD / /

Country

United States / /

Event

FDA Phase / /

Facility

University Totality / Lombardi Comprehensive Cancer Center / FDA White Oak Campus / White Oak Conference Center / /

IndustryTerm

treatment of adults with acute myeloid leukemia / /

MedicalCondition

congenital neutropenia / neutropenia / chronic administration / fever / febrile neutropenia / infection / infections / acute myeloid leukemia / severe neutropenia / idiopathic neutropenia / cyclic neutropenia / /

MedicalTreatment

leukapheresis / chemotherapy / /

Organization

office of Hematology / office of Biostatistics / office of Hematology and Oncology Products / FOOD AND DRUG ADMINISTRATION / Therapeutic Biologics office of New Drugs / Georgetown University / Oncology Products / office of Pharmaceutical Quality / office of Biotechnology Products / Oncologic Drugs Advisory Committee / Division of Hematology Products / Center for Drug Evaluation and Research / office of Translational Sciences / Clinical Pharmacology Reviewer Division / /

Person

Sigrid Balser / Opening Remarks Janet Woodcock / Toxicology Chris Sheth / Maria-Teresa Gutierrez-Lugo / Albert Deisseroth / Leah Christl / Biostatistics Sandoz Biopharmaceuticals / Caleb Briggs / Susan Kirshner / Mark McCamish / Findings Albert Deisseroth / Review Donna Przepiorka / Concluding Remarks Mark McCamish / Xiaoyu (Cassie) Dong / Sarah J. Schrieber / Deborah Armstrong / Biosimilarity Hansjoerg Toll / /

Position

Global Head of Development / Global Head / Professor and Director / Director / Chairperson / Designated Federal Officer / Medical Officer Team Leader / Head / /

Product

NEUPOGEN / EP2006 / /

ProvinceOrState

Maryland / /

Technology

Biopharmaceuticals / Biotechnology / chemotherapy / transplantation / /

SocialTag