Deputy Attorney General Lisa Monaco says the department will not seek a guilty plea when a corporation self-discloses and fully cooperates. Prosecutors to consider whether compensation systems provide incentives to promote compliance.
Deputy Attorney General Lisa Monaco issued a memo to assistant attorneys general and US attorneys that describes what companies subject to investigation and criminal prosecution can do to mitigate risk and avoid pleading guilty.
The memo revises the US Department of Justice’s criminal enforcement policies and practices. It advises prosecutors on how to ensure...
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.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
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.
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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