FDA plans to conduct a study to "further explore" the use of report card grading schemes in qualified health claims (QHCs), according to a notice published in the Federal Register May 22. The study builds off previous research that found report card schemes were effective in conveying the "intended ordering of scientific certainty," but led consumers to be more certain of "B" and "C" claims than claims of higher scientific certainty, which did not receive a grade (1"The Tan Sheet" Oct. 10, 2005, p. 7). The proposed study will attempt to correct for "misperceptions" observed in the previous study and will position unqualified claims as "A" grade claims. Additionally, the study will use actual health claims and variants of these claims rather than hypothetical claims. Green tea and cancer, coronary heart disease and consumption of monounsaturated fatty acids from olive oil as well as omega-3 fatty acids and CHD claims will be used. An earlier version of the study was proposed in March 2005 (2"The Tan Sheet" April 4, 2005, In Brief)...
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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.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
