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Gram-negative bacteria / Pseudomonadales / Aminoglycoside antibiotics / Food and Drug Administration / Tobramycin / Cystic fibrosis / Pseudomonas aeruginosa / Center for Drug Evaluation and Research / Novartis / Health / Microbiology / Medicine


Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Anti-Infective Drugs Advisory Committee Meeting September 5, 2012 Location: The FDA White Oak Campus, Building 31, The Great Roo
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City

Seattle / /

Company

MD Clinical Science Unit Head Novartis Pharmaceuticals Corporation / Novartis Pharmaceuticals Corporation / MD Therapeutic Area Safety Lead Novartis Pharmaceuticals Corporation / Development Novartis Pharmaceuticals Corporation / /

Facility

Critical Care Medicine Medical University of South Carolina Clarifying Questions / FDA White Oak Campus / White Oak Conference Center / /

IndustryTerm

cystic fibrosis treatment / inhalation solution / treatment of cystic fibrosis / /

MedicalCondition

Pseudomonas / bacterium Pseudomonas / Pseudomonas aeruginosa / cystic fibrosis / cough / MS / /

Organization

Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes / Boomer Esiason Foundation / office of New Drugs / Food and Drug Administration / Medical University of South Carolina / Pulmonary and Critical Care Medicine Medical University / FDA / Biostatistics Office / Anti-Infective Drugs Advisory Committee / Cystic Fibrosis Foundation / Information Office / Center for Drug Evaluation and Research / office of Antimicrobial Products / Advisory Committee / Division of Anti-Infective Products / /

Person

Christopher Carpenter / Brent Pace / Diane Cappelletty / Diane P. Goyette / Charles Hawkins / Christopher Kadoorie / Michael Neely / Usability Shrimant Mishra / Rodney Mullins / Efficacy Olga Santiago / Archana Chatterjee / Sheldon Kaplan / Yu Shyr / Fibrosis Bonnie Ramsey / Melvin Weinstein / Lee Becker / Peter Coderre / Thomas A. Moore / Patrick A. Robinson / Kathleen Young / Introductory Remarks John Farley / Thomas Moore (Chairperson) / Bernhard Wiedermann / Paul Auwaerter / Bruce C. Marshall / Shrimant Mishra / Monica Parise / Jerry Cahill / Linda Armstrong / Background Robert Kowalski / Julie Biller / Jesse Joad / Kurt Stevenson / John Farley / Edward Cox / Joan Hilton / /

Position

JD Designated Federal Officer / Federal Officer / PharmD Global Head / Drug Regulatory Affairs US Head / Professor / Chairperson / MPH Acting Director / Designated Federal Officer / Representative / Director / Center / /

Product

TOBI / tobramycin / /

ProvinceOrState

Maryland / South Carolina / /

Technology

pharmacodynamics / /

URL

http /

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