By Michael McCaughan
FDA convened a briefing for the media with the staff of its Drug Safety Oversight Board on Aug. 25. The...
A media briefing with the professional staff of the Drug Safety Oversight Board offered a rare opportunity for a public conversation about the activities of the group. The discussion touched on the likely role of the board in the upcoming Avandia decision, the appropriateness of closed door meetings in an era of transparency, and the evolving focus of the group five years after its formation.
By Michael McCaughan
FDA convened a briefing for the media with the staff of its Drug Safety Oversight Board on Aug. 25. The...
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.