Rx Review Management Office Acting Head Is ODE IV Deputy Kweder
Acting Office of Review Management Director Sandra Kweder, MD, is the fourth person to fill the top FDA drug review position in the past six months.
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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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