Soliris REMS Should Be Modified, Not Eliminated, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Alexion’s risk management program could benefit from easing current requirement for MedGuide distribution with every infusion and streamlining surveys of prescribers’ knowledge about meningococcal risks.
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FDA advisory committee will weigh potential tweaks to orphan drug’s risk management plan, which is meeting informational goals regarding meningococcal infections but could be burdening prescribers with repeated assessments.
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.
Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.