FDA Widens Expanded Access, Will Accelerated Approval Gray Area Narrow?
FDA's development of two rules to broaden the use of expanded access programs suggests the agency is continuing to position such programs as alternatives to accelerated approval
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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