Is the Food & Drug Administration on a path towards 100% user fee funding? It just might be, says Alan Goldhammer.
Not just FDA, actually: given the overall budget climate, Goldhammer said during the Food & Drug Law Institute annual meeting...
The share of drug reviews funded by industry fees has climbed steadily over two decades, and is going to jump again once generic drug and biosimilar fees become reality. It may be time to move to an all user fee model for drug reviews.
Is the Food & Drug Administration on a path towards 100% user fee funding? It just might be, says Alan Goldhammer.
Not just FDA, actually: given the overall budget climate, Goldhammer said during the Food & Drug Law Institute annual meeting...
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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.’
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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