Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance
FDA should re-evaluate when it issues warning letters, and the language it uses within them, given the collateral damage they can cause for pharmaceutical manufacturers, industry attorneys said at the recent Food and Drug Law Institute (FDLI) annual meeting.
During a panel discussion on Center for Drug Evaluation and Research (CDER) activities and priorities, industry attorneys questioned whether the...
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.
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.
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.
