FDAAA Cornucopia: REMS To Be Used Sparingly; Trial Database On Schedule
FDA will use its authority to require risk evaluation and mitigation strategies judiciously, according to Chief Medical Officer and CDER Acting Director Janet Woodcock
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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