Establishment Fees Protect American Manufacturing, Mylan Argues In User Fee Proposal
Mylan President Heather Bresch is drawing attention to the economic implications of not inspecting overseas drug manufacturing facilities as she seeks congressional support for generic user fees to finance such activities.
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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