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...
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