Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, FDA officials tell the Pink Sheet.
The extra time the US Food and Drug Administration took to produce guidance on live remote video plant tours reflects the agency’s enthusiasm for them, not a reluctance to supplement inspections with them during the pandemic, agency officials told the Pink Sheet.
The FDA produced a blizzard of COVID-19-related guidance documents in the spring and summer of 2020, including some that were...
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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