Vegetable Oil Sterol Esters Heart Disease Claim Sought By Lipton

Spreads and salad dressings bearing a proposed health claim for vegetable oil sterol esters (VOSE) and a reduced risk of heart disease should be exempted from "total fat" and "low fat" disqualifying levels, Lipton urges FDA in a citizen petition recently made available by the agency. Certain levels of fat and cholesterol can prevent an otherwise qualified product from being able to use a health claim.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
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This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
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A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
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Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
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The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.