FDA Safety Monitoring Could Rely On Data Links, Menactra Model – McClellan
Former FDA Commissioner Mark McClellan was one of the main drivers behind the language in the FDA Amendments Act mandating an active surveillance system, and he continues to be involved in shaping the program how will be implemented
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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