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US FDA rejects antibiotic non-inferiority studies for bronchitis

This article was originally published in Scrip

Executive Summary

A new US FDAdraft guideline formally rejects the use of non-inferiority studies in the development of antimicrobial drugs for acute bacterial exacerbations of chronic bronchitis (ABECB), making clear that only superiority trials are recommended. The document stresses the importance of clinical benefit as an outcome and relies heavily on the use of patient-reported measures in assessing efficacy.


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