US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
The US Food and Drug Administration’s inspectorate has remained focused on the pharmaceutical industry’s pandemic response as the spreading Delta variant deferred hopes of turning the corner on the COVID-19 pandemic.
FDA investigators recently found issues at the plant where Eli Lilly and Company fills vials with COVID-19 antibody cocktails.
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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