Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Executive Summary
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.
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Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal
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