It's Up To Stakeholders To Further The PRO Measurement Field, FDA Said
FDA is preparing to issue its final guidance on patient-reported outcomes soon - which will codify the agency's approach to validating PROs used as clinical endpoints - but a recent workshop made clear that there is still a substantial amount of work to be done on identifying and creating appropriate measurements of patient-, clinician- and caregiver-reported outcomes
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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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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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