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Clinical research / Biotechnology / Therapeutics / United States Public Health Service / Center for Drug Evaluation and Research / Biopharmaceutical / Biosimilar / Biologic / 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. / PhD / FDA EP2006 Chemistry Manufacturing / APPLICANT PRESENTATIONS Sandoz Inc. / Sandoz Inc. / /

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 / Review Chemistry Reviewer Division of Therapeutic Proteins / FOOD AND DRUG ADMINISTRATION / Therapeutic Biologics office of New Drugs / Georgetown University / 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 / office of Clinical Pharmacology / /

Person

Sigrid Balser / Biosimilar Susan Kirshner / Opening Remarks Janet Woodcock / Toxicology Chris Sheth / Pharmacology Sarah Schrieber / Maria-Teresa Gutierrez-Lugo / Albert Deisseroth / Leah Christl / Biostatistics Sandoz Biopharmaceuticals / Caleb Briggs / Mark McCamish / Xiaoyu (Casse) Dong / Review Donna Przepiorka / Concluding Remarks Mark McCamish / Biosimilarity Joerg Windisch / Deborah Armstrong / /

Position

Chief Science Officer / Global Head / Professor and Director / Director / Chairperson / PharmD Designated Federal Officer / Medical Team Leader / Global Head of Development Sandoz Biopharmaceuticals Analytical Demonstration / /

Product

NEUPOGEN / EP2006 / /

Technology

Biopharmaceuticals / Biotechnology / chemotherapy / transplantation / /

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