Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.
While compounding and opioids will continue to be high enforcement priorities for the US FDA and Department of Justice (DoJ) in the year ahead, biopharma manufacturers need to keep an eye on additional areas of legal risk, including Risk Evaluation and Mitigation Strategy (REMS) violations, misleading drug promotion, and reimbursement support services.
In speeches and panels at the recent Food and Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference, leaders from...
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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