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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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.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
