FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy
Unapproved drugs that "present direct challenges" to FDA's new drug approval and OTC drug monograph systems will be high priority for enforcement actions, according to an agency guidance released June 8
Learn what's happening at the US FDA. On the go.
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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.
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