GDUFA Timetable Unclear, But Negotiations Will Begin With Lots Of Agreement - Except For Mylan
Coalition and GPhA expect to be on the same page at FDA public meeting, but Mylan proposes alternative user fee structure based on establishment fees.
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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