Unfinished Labeling Business: Pregnancy, In Vitro Data, Containers
FDA's final labeling rule defers revisions to labeling issues such as the content and format of the Pregnancy subsection, inclusion of in vitro data and the requirements for container labels
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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