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Welcome to VMAC

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

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  1. Welcome to VMAC Comments by Dr. Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Veterinary Medicine October 13, 2004 Rockville, Maryland

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

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

  9. 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

  10. Additional Experts • John Powers, M.D. • Mike Apley, D.V.M.,

  11. 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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