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Guidances Will Address NDI “Misperceptions,” Energy Drinks

 
• By Elizabeth Crawford

FDA is working on two guidances that will affect the supplement industry: a revised new dietary ingredient notification draft guidance and a drinks guidance that will address whether energy drinks are supplements or conventional foods, CFSAN director Michael Landa said.

FDA will revise its controversial draft guidance on new dietary ingredient notifications to clarify “misperceptions” industry stakeholders reported about the draft released in July 2011, food center director Michael Landa said.

The agency will not withdraw the guidance, as requested by some in the dietary supplement industry and Congress, because it...

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
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The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

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

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

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.