FDA Finalizing Opioid REMS Proposal, Sets Joint Advisory Committee Meeting For July
FDA wants to gather feedback from advisors and from the public on the classwide REMS for opioid analgesics, and judging from the stakeholder meetings the agency has held so far, it will get an earful.
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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