REMS And Benefits? FDA, Industry Debate Moving Beyond Safety Information
Included in FDA's upcoming look at improving Risk Evaluation and Mitigation Strategies may be an adjustment to Medication Guides to include drug benefits alongside risks
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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