The REMS Double Down: Two Indications, Two REMS For Ovation’s Sabril?
If FDA follows an advisory committee's advice to approve Ovation's Sabril (vigabatrin) for two separate epilepsy indications, it may require a first for the REMS era: two Risk Evaluation and Mitigation Strategies for a single product
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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.
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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.’
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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.
