FDA May Revisit Antidepressant “Black Box” Suicidality Warning
FDA will monitor emerging data on suicides and antidepressants as it becomes available to determine if an uptick in suicides among adolescents is associated with the decline in prescriptions for antidepressants that followed the addition of a "black box" warning to labeling for the products
Learn what's happening at the US FDA. On the go.
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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.
