NLEA PROPOSED RULE ALLOWING "SPLIT" CLAIMS, "ANCHORED" SYNONYMS IMMINENT, FDA Office of Food Labeling Director Edward Scarbrough, PhD, announced at a Dec. 12 session of the Food and Drug Law Institute's annual educational conference in Washington, D.C. Scarbrough indicated that a proposed rule responding to the National Food Processors Association's request for revision of certain Nutrition Labeling and Education Act requirements is likely to appear in the Federal Register within days.
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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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Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.