The US Food and Drug Administration has unveiled its final guidance on what makers of brand-name opioids need to do to obtain abuse-deterrent language in the labeling of their products1-3.
The US Food and Drug Administration has unveiled its final guidance on what makers of brand-name opioids need to do to obtain abuse-deterrent language in the labeling of their products1-3.
The document, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling, describes the FDA's expectations on the types of studies...
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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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