FDA’s “Complete Response” Letters May Not Be Complete Enough For Firms
FDA's "complete response" final regulations finally do away with negative connotations of the "not approvable" label used by the agency since the 1990s, but they will not provide more certainty for sponsors about how to answer FDA's problems with an application
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.’
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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