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Welcome to VMAC Comments by Dr. Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Veterinary Medicine October 13, 2004 Rockville, Maryland Purpose of Meeting First macrolide under Guidance for Industry #152 Pfizer Animal Health application for use of tulathromycin in cattle, swine

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Welcome to vmac l.jpg

Welcome to VMAC

Comments by

Dr. Stephen F. Sundlof, D.V.M., Ph.D.

Director

Center for Veterinary Medicine

October 13, 2004

Rockville, Maryland


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Purpose of Meeting

  • First macrolide under Guidance for Industry #152

    • Pfizer Animal Health application for use of tulathromycin in cattle, swine

  • CVM reviewed microbial safety information

  • Asking VMAC for input on assessment


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Committee Members

  • Arthur L. Craigmill, Ph.D., University of California

  • Sherman (Skip) W. Jack, D.V.M., Ph.D., College of Veterinary Medicine, Mississippi State


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Committee Members

  • John J. McGlone, Ph.D., Texas Tech University and Health Sciences Center

  • Lisa Nolan, D.V.M., Ph.D., Iowa State University

  • Mark G. Papich, D.V.M., College of Veterinary Medicine, North Carolina State University


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Retiring Committee Members

  • VMAC Chair, John T. Waddell, D.V.M., Sutton Veterinary Clinic, P.C., Sutton, Nebraska

  • Marguerite Pappaioanou, D.V.M.,Ph.D., Office of Global Health, Centers for Disease Control and Prevention

  • Dennis P. Wages, D.V.M., North Carolina State University, College of Veterinary Medicine


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Consultants, Future Committee Members

  • Susanne Aref, Ph.D., Department of Statistics, Virginia Polytechnic Institute and State University

  • Gregory Jaffe, Center for Science in the Public Interest


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Consultants, Future Committee Members

  • Katrina L. Mealey, D.V.M., Ph.D., Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University

  • Richard A. Sams, Ph.D., Ohio State University, Analytical Toxicology Laboratory, Ohio State University Veterinary Hospital


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Supplemental Expertise

  • James E. Leggett, Jr., M.D.,Chair of CDER’s Anti-Infective Drugs Advisory Committee, Oregon Health Sciences University


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AIDAC Consultants

  • Nathan Thielman, M.D., Duke University Medical Center

  • Christopher Ohl, M.D., Wake Forrest University

  • L. Barth Reller, M.D., D.T.M.&H., Duke University Medical Center


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Additional Experts

  • John Powers, M.D.

  • Mike Apley, D.V.M.,


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Historic Meeting

  • Drug under review is a macrolide, a Category I drug, thus eligible for VMAC review under Guidance for Industry #152

  • Qualitative risk assessment of drug

  • Transparent, open public meeting


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