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US Capitol Capsule: Charting a new course for antibiotics

This article was originally published in Scrip

Executive Summary

While the FDA last week again signaled it would like to see the process expedited for developing drugs to treat serious bacterial diseases in patients with unmet medical needs, including those infections for which currently available therapies do not respond, or drug-resistant bacteria – outlining approaches in a new guidance document for streamlining the development of those medicines – the agency, nonetheless, emphasized it was not creating any sort of a new pathway for approving those products. At least, not yet.

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