The European Commission and German health technology assessors have poured cold water on aspirations by European Medicines Agency head Guido Rasi to introduce an adaptive licensing approach for evaluating and approving medicines.
The European Commission and German health technology assessors have poured cold water on aspirations by European Medicines Agency head Guido Rasi to introduce an adaptive licensing approach for evaluating and approving medicines.
Adaptive licensing – under which drugs would be approved earlier on than at present and on the basis of less...
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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.
