Whatever the ultimate outcome turns out to be for the debates in the US over the naming of biosimilars or prescriber notification of interchangeable products, the medicines are bound to be "among the most deeply analyzed and predictable" drugs to hit the US market, said Dr Emily Shacter, a former Food and Drug Administration official and now an independent consultant with ThinkFDA.
Whatever the ultimate outcome turns out to be for the debates in the US over the naming of biosimilars or prescriber notification of interchangeable products, the medicines are bound to be "among the most deeply analyzed and predictable" drugs to hit the US market, said Dr Emily Shacter, a former Food and Drug Administration official and now an independent consultant with ThinkFDA.
"I can assure you that all scientific rigor will be brought to bear," Ms Shacter declared at a 4 February...
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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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