US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.
The US FDA has named the first eight European drug regulatory authorities that it is recognizing under a US/EU mutual recognition agreement reached in March.
It will now be the exception rather than the rule for FDA to inspect pharmaceutical manufacturing facilities in these countries:...
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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