Generic Exclusivity Forfeiture Provisions Put FDA In “Hot Seat”
FDA is grappling with how to define triggers for forfeiture of generic exclusivity as it develops regulations to implement changes in Hatch/Waxman created by the Medicare Modernization Act of 2003
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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