Manufacturing US regulatory updates for December 2017: Elemental impurities requirements begin Jan. 1, final guidance confirms BCS Class 3 biowaivers option, and FDA MAPP implements USP salt policy.
FDA Dec. 21 posted a reminder on its website that all applications filed after Jan. 1 for authority to market new and generic USP monograph drugs in the US must meet new requirements in USP general chapters <232> and <233> for control of elemental impurities.
In addition, FDA expects new and abbreviated drug applications for non-compendial drugs to follow the recommendations in the International Council...
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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