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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

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
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
committee members
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
committee members4
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
retiring committee members
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
consultants future committee members
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
consultants future committee members7
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
supplemental expertise
Supplemental Expertise
  • James E. Leggett, Jr., M.D.,Chair of CDER’s Anti-Infective Drugs Advisory Committee, Oregon Health Sciences University
aidac consultants
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
additional experts
Additional Experts
  • John Powers, M.D.
  • Mike Apley, D.V.M.,
historic meeting
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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