For the first time since the user fee program was created, industry-supported lobbying groups have formed to help win a bigger budget for FDA. Stakeholders are optimistic they'll be successful.
On the face of it, it’s a bizarre concept: the drug industry working as part of a broad-based coalition with patient groups and former government health officials to try to get more money for the Food & Drug Administration.
But what might be more bizarre is that it’s happened twice: since the start of the negotiations surrounding the reauthorization...
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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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