Vioxx Settlement Down, Merck Has Three More Government Probes Pending
Sales rep call notes on Vioxx off-label promotion were a key part of the government’s criminal case against Merck; $950 million settlement includes a new corporate integrity agreement that requires monitoring of call notes.
Learn what's happening at the US FDA. On the go.
More from Compliance
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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
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A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
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The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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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.
