After receiving delayed visas, additional FDA is inspectors and other staff can relocate to China office; Gottlieb also announces increase in international mail facility staff.
FDA is sending more staff out to foreign offices to enhance product safety and quality while at the same time bolstering border protection at home to improve drug supply chain security.
Specifically, it now appears FDA's Beijing office may be growing. Expansion plans had been hampered by delays FDA staff in...
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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