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US FDA Converges With Other Regulators On Insomnia Drug Warnings, But Broader Safety Disagreements Persist

 
• By Michael Cipriano

US FDA will add boxed warnings to insomnia drugs, bringing it in line with other regulators, even as a study in JAMA Internal Medicine study indicates that national drug authorities often disagree more broadly over when to issue safety advisories.

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A set of insomnia drugs will come with more restrictive labeling.

Despite a broader trend of disagreement among national pharma regulators over instances for which to issue drug safety alerts, there appears to be some degree of convergence on warnings regarding certain insomnia drugs.

The US Food and Drug Administration issued a drug safety communication on 30 April announcing that it would be adding...

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The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
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The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.