Roche Accutane “Fallback” Risk Plan May Test FDA Authority Over Registries
Risk management concerns over Roche's Accutane could re-open the issue of whether FDA can require patient registries and limited distribution programs
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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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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.
