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Viral diseases / Monoclonal antibodies / Vaccination / Palivizumab / Human respiratory syncytial virus / Vaccines / MedImmune / Bronchiolitis / Motavizumab / AstraZeneca / Health / Medicine


U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. This content has not been altered or updated since it was archived
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City

Washington DC / /

Company

11 Applicant Presentation MedImmune LLC / Washington Business Journal / MedImmune LLC / Merck Research Laboratories / CARGILL / /

Country

United States / /

Event

FDA Phase / /

Facility

Stanford University / Medical College of Wisconsin / University of Utah / Laboratory of Clinical Infectious Diseases / Montgomery County Circuit Court / University of Texas / University of Pennsylvania School / a.m. Hilton Washington DC/Silver Spring Maryland Ballroom / Children's Hospital / MCG Medical Center / University of Vermont / University of Rochester / Nationwide Children's Hospital / Kansas City University of Medicine / /

IndustryTerm

investigational site / travel expenses / prevention of serious lower respiratorytract disease / prevention of serious lower respiratory-tract disease / /

MedicalCondition

congenital heart disease / severe RSV infection / anaphylaxis / complicated congenital heart disease / hemodynamically significant congenital heart disease / respiratory-tract infection / severe disease / both bronchiolitis / pediatric infectious diseases / pneumonia / CHD / pulmonary function / Allergy / fever / bronchiolitis / AIDS / infection / fatal RSV infection / serious RSV disease / acute respiratory-tract illness / RSV infections / RSV disease / hypersensitivity / MS / influenza / serious lower respiratory-tract disease / wheezing / serious lower respiratorytract disease / premature birth / disease / gastroenteritis / RSV lower respiratorytract infection / pulmonary hypertension / atelectasis / RSV bronchiolitis / chronic lung disease / Infectious Diseases / serious lower respiratory-tract infection / inflammation / acute infection / lower respiratory-tract infections / dehydration / /

MedicalTreatment

surgery / immunosuppression / /

OperatingSystem

Microsoft Windows / /

Organization

University of Pennsylvania School of Medicine / Antiviral Committee / Public Health office of AIDS / Division of Antiviral Products / Division of Gastroenterology and Hepatology / UNITED STATES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH ANTIVIRAL DRUGS ADVISORY COMMITTEE BLA / Antiviral Drugs Advisory Committee / University of Rochester / Medical College of Wisconsin / office of AIDS Research / University of Texas / San Antonio / Division of Gastroenterology / California Department / MCG Medical Center / University of Utah / Department of Medicine / office of Antimicrobial Products / Nationwide Children's Hospital in Columbus / City University / National Institute of Health / University of Vermont / Laboratory of Clinical Infectious Diseases / Department of Pediatrics / Division of Inpatient Pediatrics / Antiviral Advisory Committee / Vaccine Research Center / Congress / Division of Infectious Diseases / U.S. Food and Drug Administration / Stanford University / Antiviral Drug Advisory Committee / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH AND HUMAN SERVICES / /

Person

Doris Strader / Paul T. Tran / Ed Cox / Jules O'Rear / Debra Birnkrant / Yvonne A. Moldonado / D. Alan Shapiro / Ross Lobell / D. Athena F. Zuppa / D. Michelle E. Roland / Pam Griffin / Edward Cox / Bill Tauber / Enrico P. Veltri / Yoshi Murata / Craig W. Hendrix / Alan Shapiro / Kurt Hagedorn / Debra B. Birnkrant / D. Amneris E. Luque / D. Susan S. Ellenberg / Prescott (Thomas) Atkinson / Alexandra F. Freeman / Susan Ellenberg / Gregory Geba / Pamela Griffin / Michelle Roland / Octavio Ramilo / Patrick G. Clay / Angelica D. Walden / Genevieve Losonsky / Erica Jefferson / Victoria Cargill / Nark Boguniewicz / M.D. William Tauber / Peter Havens / D. Barney S. Graham / Curt H. Hagedorn / D. Doris B. Strader / Shawn L. Ralston / Victoria A. Cargill / M.S. Yoshihiko Murata / Yvonne Maldonado / /

Position

professor of pediatrics and Chief / Microbiology Team Leader / Antiviral Products / non-voting industry representative / invited industry representative / bench-level and clinical researcher / consultant and a member / Director / Acting Chair / chair / medical officer / Industry Representative / Director / Regulatory Affairs / /

Product

Synagis / CP110 / CP117 / /

ProgrammingLanguage

DC / /

ProvinceOrState

Ohio / Utah / California / Texas / Vermont / Wisconsin / /

PublishedMedium

Clinical Infectious Diseases / the Washington Business Journal / /

SportsLeague

Stanford University / /

Technology

cell phones / antibodies / /

SocialTag