The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized.
The US Food and Drug Administration has been called on to explain when its long-overdue drug guidance on the so-called animal rule is likely to be finalized.
It has been nearly two years since Congress passed a measure requiring the FDA to issue the final guidance, but...
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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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