CMS/FDA Parallel Review: Agencies Weighing Process For Planning Trials That Satisfy Both
CMS and FDA are considering a voluntary process that would help drug, biologic and medical device sponsors design clinical trials that would ultimately support both FDA approval and CMS national coverage decisions for Medicare reimbursement.
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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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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