PDUFA Old School: Industry Wants User Fees To Get Back To Basics
User fees should be spent on improving drug assessments, not funding everybody's wish list for FDA action, Genzyme policy advisor tells DIA
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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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