US FDA's antibiotic task force: A new dawn or just more guidance tinkering?
This article was originally published in Scrip
Over the past few years, the US FDA has held numerous public hearings seeking input from antibacterial makers on what the agency should do to update existing guidances and create new documents to help steer manufacturers down the best path in designing trials and choosing the most appropriate endpoints to support the efficacy of their products – with the outcomes of those forums not always pleasing to some in the industry.
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