ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five
The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.
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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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