Patient-Reported Outcomes Instruments Need Validation Before Pivotal Trials
Patient-reported outcomes instruments should be validated prior to use in a pivotal clinical trial, FDA Antimicrobial Drug Development & Resistance Initiatives Lead Medical Officer John Powers told a Drug Information Association webinar on FDA's PRO draft guidance April 5
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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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