IoM Drug Safety Study May Buy Time For FDA; Report Will Play In PDUFA IV
FDA's decision to proceed with an Institute of Medicine review of drug safety regulation could trigger a full-fledged debate over the possibility of creating a separate post-marketing regulatory agency in the U.S
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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