The French government has launched a pilot project1 intended to allow drug companies to familiarize themselves with the new procedures that will kick in when the provisions of the EU's Clinical Trials Regulation take effect in a couple of years' time.
The French government has launched a pilot project1 intended to allow drug companies to familiarize themselves with the new procedures that will kick in when the provisions of the EU's Clinical Trials Regulation take effect in a couple of years' time.
Led by the French drug regulator, the Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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.
