FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING
AGENDA
January 9, 2003
Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD
Topic: Ranking of Antimicrobial Drugs According to Their Human Importance in Human Medicine (Appendix A of "Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern")
9:00 a.m. Call to Order
James E. Leggett, Jr., M.D.Acting Chair, AIDAC
Introduction of Committee
Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC
Opening Comments Mark Goldberger, M.D., M.P.H.
Director
Office of Drug Evaluation IV
Food and Drug Administration
9:15 a.m. Overview Linda Tollefson, D.V.M., M.P.H.
Deputy Director
Center for Veterinary Medicine
Food and Drug Administration
9:45 a.m. Explanation of Antimicrobial Risk Assessment Mary Bartholomew, Ph.D.
Mathematical Statistician Biometrics Team
Center for Veterinary Medicine
Food and Drug Administration
10:15 a.m. Ranking of Antimicrobial Drugs Relative Richard Carnevale, V.M.D. to Their Use in Animals Vice President Scientific, Regulatory and
International Affairs
Animal Health Institute
10:45 a.m. Questions from Committee
11:00 a.m. Break
11:15 a.m. Relating Food Animal and Human Mike Apley, D.V.M., Ph.D.
Antimicrobial Use
Veterinary Diagnostic and Production Animal Medicine
Iowa State University
American Veterinary Medical Association
11:45 a.m. Questions from Committee
12:00 p.m. Process of Ranking of Drugs by Importance in John H. Powers, M.D.
Human Medicine Lead Medical Officer for
Antimicrobial Drug Development
Office of Drug Evaluation IV
Food and Drug Administration
12:30 p.m. Lunch
1:30 p.m. Open Public Hearing
2:30 p.m. Summary and Charge to Committee
Mark Goldberger, M.D., M.P.H.
2:35 p.m. Committee Discussion
2:30 p.m. Break
3:55 p.m. Concluding Comments Mark Goldberger, M.D., M.P.H.
4:00 p.m. Adjourn