Generic Liability: Supreme Court Appears Divided On Whether ANDA Sponsors Must Seek Label Change When New Risks Emerge
In oral arguments in Pliva v. Mensing, justices suggest generic companies have an obligation to ask FDA to revise labeling; Chief Justice John Roberts Jr. says that could lead to boilerplate letters to FDA.
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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