Clinicians and product sponsors want to be able to leverage off-label efficacy data for antibacterial drugs. However, the answer may lie not so much in broadening the label’s scope but, rather, in the development of rapid, peer-to-peer critiques of such data to help guide clinical use, stakeholders suggested at a recent US Food and Drug Administration workshop on antibacterial drug development.
At a meeting cosponsored by the Infectious Diseases Society of America, National Institutes of Health and Pew Charitable Trusts, clinicians and sponsors urged the agency to open up antibacterial labeling to include more data that could better inform clinical practice, such as