Public Health Trumps User Fee Goals, FDA Leaders Say – But That May Be Good News For Sponsors
FDA wants to be judged on its overall impact on public health - not on drug approvals - Commissioner Margaret Hamburg and Principal Deputy Joshua Sharfstein say in an 1editorial published in the New England Journal of Medicine May 26
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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