FDA May Require NDA Pre-Filing Meeting Under PDUFA V Review Model; Pilot Launching Soon
The new application review process being negotiated as part of the PDUFA V reauthorization is nearing the pilot stage and could require sponsors to have the bulk of their information ready before submission.
Learn what's happening at the US FDA. On the go.
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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