FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

QUESTIONS TO THE COMMITTEE

February 20, 2002

Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

Topic: Approaches to the development of antimicrobial agents for the treatment of resistant pathogens

 

Based upon the presentations at this meeting and your knowledge and experience in the field, please discuss the following issues regarding drug development for resistant pathogens:

  1. What are the barriers/challenges that hinder drug development for resistant pathogens? In your discussion please consider the following types of development programs:

How do we overcome these challenges and barriers while assuring that drugs are shown to be safe and effective for their intended use?

 

  1. Based upon the presentation from this morning, please comment on a focused drug development approach for resistant pathogens. In your discussion, please discuss the following:

 

  1. Please discuss any alternative strategies or approaches the Committee wishes to propose for the development of drugs for the treatment of resistant pathogens.
  2.  

  3. Please discuss strategies or approaches the Committee wishes to propose for "preserving the efficacy" of currently marketed antimicrobials, i.e., to prevent development of antimicrobial resistance.