US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
While the US Food and Drug Administration redeploys investigators barred by the US State Department from conducting inspections in China due to novel coronavirus risks, the health secretary says he is open to working with Congress on legislation to help the pharmaceutical industry reduce its dependence on manufacturing in China.
Meanwhile, a pre-coronavirus inspection of a crude heparin manufacturer in China identifies irregularities in record keeping and data integrity that...
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.
