FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

POINTS FOR DISCUSSION

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Topic: Ranking of Antimicrobial Drugs According to Their Human Importance in Human Medicine (Appendix A of "Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern")

 

  1. Please discuss the factors used to rank drugs according to their importance in human medicine:

 

A. Are the factors used to determine the importance of drugs adequate?

 

 

B. Are there factors that should be added or subtracted?

 

 
  1. Are some factors more important than others? Should they be weighted according to importance?

Which are most important?