US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.
US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.
In addition, Food and Drug Administration commissioner Margaret Hamburg said she was invoking her authority to require ER/LA opioid manufacturers...
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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.’
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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