ANTIMICROBIAL DATA POOLING ACROSS INFECTION SITES COULD BE ACCEPTABLE TO SUPPORT EFFICACY AGAINST DRUG-RESISTANT STRAINS, FDA ADVISORY COMMITTEE SUGGESTS
Executive Summary
Clinical data on drug-resistant bacteria strains could be pooled across infection sites and organized by strain in NDA submissions for some antimicrobial indications, stated Committee Chairman William Craig, MD, Middleton Memorial Veterans Hospital (Madison, Wisc.), at a July 26 meeting of FDA's Anti-Infective Drugs Advisory Committee.