HHS will take steps to increase access to abortion medication and prevent states from banning it, Secretary Becerra says, but also is questioned about whether the FDA can speed up certification of pharmacies and if the Justice Department would sue states banning access.
The Biden Administration plans to increase access to the abortion pill Mifeprex (mifepristone) as a way to lessen the devastating impact of the US Supreme Court’s overturning Roe v. Wade. While it has presented no specifics on how it will do so, the US Food and Drug Administration could have a significant role in the endeavor.
Health and Human Services Secretary Xavier Becerra announced at a 28 June press briefing that ensuring access to medication abortion...
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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