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…blogged, that was FTC’s first case targeting health claims related to a mobile medical app sold in Apple’s iTunes Store and Google’s Android Marketplace under the names “AcneApp” and “Acne…
…fact: The story of Rudolph was originally written in 1939 by Robert May as a booklet for Montgomery Ward, a department store. May’s brother-in-law, songwriter Johnny Marks, later adapted the…
…of “menu” and the related requirement to provide nutritional information in establishments where consumers are not usually physically present when ordering items, the application of the law to grocery stores…
…its first case targeting health claims related to mobile medical apps. The mobile apps, sold in Apple’s iTunes Store and Google’s Android Marketplace under the names “AcneApp” and “Acne Pwner,”…
…review of similar claims, and that 85% of such claims have been rejected due to a lack of scientific support. Similarly, Canada has initiated review of structure/function claims, most of…
…regulatory framework, if any exists for cell-cultured food products and how this framework compares to other international approaches,” e.g., those in Canada, Japan, and the European Union. According to the…
…“relied on the international consensus reflected in the World Health Organization’s Framework Convention on Tobacco Control” and also reviewed “the use of a nearly identical warning requirement in Canada.” The…
…by the EU. This issue is not unique to Europe. In the United States, the debate continues as to whether Americans should be allowed to re-import prescription drugs from Canada…
…(the “Martek notification,” effective since May 22, 2005); and a notification concerning nutrient content claims for DHA and EPA submitted by Ocean Nutrition Canada, Ltd (permitted since April 9, 2006…
…price in any “high income country” (defined in the Act as the U.K., Germany, Canada, and Australia), the manufacturer was presumed to be in violation of the law. The burden…
…the Royal Bank of Canada and Jonathan Orszag, former Director of the Office of Policy and Strategic Planning and member of President Clinton’s National Economic Council – supporting the proposition…
…(PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. See our prior blog post on the topic here. FDA announced that FDA, Health Canada, and MHRA are jointly publishing guiding principles…
…drug’s price exceeds an Average International Market (AIM) price. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K. A…
…life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier…
…And because it’s unlikely that FDA, the European Commission, or Health Canada are going to relax any of their regional requirements for safety and efficacy, the generic standards adopted are…