Agency has seen ‘a good slate of applicants’ for the post of associate commissioner for regulatory affairs, who will oversee a revamped field organization focused on inspections, investigations and imports. New update to the reorg plans calls for medical product and specialty labs to be moved out of the Office of Regulatory Affairs and relocated to the Office of the Chief Scientist.
What kind of person is the US Food and Drug Administration seeking to fill the position of associate commissioner for regulatory affairs?
“Barking cat is probably the best description,” FDA Commissioner Robert Califf said during a 22 August webinar hosted by the...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
