Can A REMS Block A Generic? Thalomid Could Be Early Test
Celgene's arguments against generics of Thalomid (thalidomide) offer another example of the potentially vast consequences of FDA's new safety powers: The firm is arguing that the complexity of its risk management plan precludes the approval of alternate versions of the product
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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