Pre-Emption Battle Looms In Supreme Court As FDA Finalizes Labeling Rule
FDA's final rule on sponsors' obligations to update their labels alters the definition of "newly acquired information" from the proposed rule while leaving the remainder intact. The change could be a boon to industry, but a slap to Democrats who had called for the rule's withdrawal
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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