US Capitol Capsule: FDA ponders 'limited use' status for antibiotics, other meds
This article was originally published in Scrip
Under pressure from professionals in the infectious diseases community and the biopharmaceutical industry, the US FDA is considering the feasibility of adopting a mechanism where regulators could designate special limited medical use for certain drugs to treat serious and life-threatening conditions, allowing manufacturers to take a streamlined development approach, with shorter studies involving fewer patients than currently required.
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