Requirements for research and labeling of systemic antimicrobial drug microbiology by FDA / 药物评价研究

ABSTRACT

FDA in August 2016 released Microbiology Data for Systemic Antibacterial Drugs —— Development,Analysis,and Presentation Guidance for Industry,which introduced requirements of the whole process of the research on the microbiology of systemic antimicrobial drugs by FDA.Therefore,the guidance of FDA has an important reference value for the research and supervision of the systemic antimicrobial drugs in our country.The following are particularly noteworthyrequirements for the in vitro AST methods,the QC parameters and the AST interpretive criteria;Requirements for the format and content of the labeling microbiology portion;requirements for periodic evaluation and update of the in vitro AST methods,the QC parameters,and the AST interpretive criteria in postmarketing labeling;Requirements for the number of isolates and the characteristics of pathogenic bacteria for in vitro sensitivity test.