FDA issues draft guidance on chronic bronchitis

FDA issued draft guidance on the development of antimicrobial drugs to treat acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD). The guidance, which revises draft guidance on the topic published in 1998, recommends using only superiority trials for ABECB-COPD studies. FDA said non-inferiority trials are not considered adequate to establish evidence of effectiveness for regulatory approval for the indication. ...