Guidance for Industry: Acute Bacterial Sinusitis: Developing Drugs for Treatment.

摘要

The purpose of this guidance is to assist sponsors in the clinical development of drugs2 for the treatment of acute bacterial sinusitis (ABS). This guidance defines ABS as inflammation of the paranasal sinuses as a result of the presence of a bacterial pathogen within the sinus space when the duration of illness is less than 4 weeks. Specifically, this guidance addresses the Food and Drug Administrations (FDAs) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of ABS. This guidance does not address the development of drugs for other purposes such as prevention of ABS or treatment of chronic sinusitis, or developing drugs for the nonantimicrobial treatment of sinusitis. This guidance does not contain discussion of the general issues of clinical trial design or statistical analysis. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials.