In a reminder that the agency hasn't forgotten past tragedies, FDA warns Philippine OTC firm Skin Sciences to test glycerin raw material for diethylene glycol if it wants to keep selling toothpaste in the US.
A July 28 US FDA warning letter to Skin Sciences Laboratory Inc., an over-the-counter drug maker in Pasig City, the Philippines, serves as a reminder for drug manufacturers to test any glycerin raw material for diethylene glycol, or DEG, a molecule that in many ways resembles glycerin, but is poisonous.
It was diethylene glycol in S.E. Massengill Co.'s elixir sulfanilamide that killed more than 100 US patients in a 1937...
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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