Orphan Products Mostly Approved With Regulatory Flexibility, NORD "Catalog" Finds
The National Organization for Rare Disorders’ campaign to get FDA to codify a flexible approach on approving orphan drugs is now bolstered by an analysis that concludes most of the agency’s approval decisions for such products already use unconventional efficacy standards.
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.’
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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