…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…

…Ontario, Canada, citing it for limiting and delaying FDA’s inspection based on the following conduct: The Quality Manager “shoving and shouting at our investigators for conducting the inspection without [his]…

…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…

…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…

…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…

…China, Germany and Canada, all saw net increases in the number of manufacturing sites in inventory over the past three years. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537…

…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…

The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995. In most countries, such as Mexico and Canada, and regions,…

…regulatory agencies in the United States, Canada, Europe, and Japan . . . that current levels of exposure to BPA through food packaging do not pose an immediate health risk.”…

…a February 2003 letter issued in response to inquiries about the liability of various parties involved in importing prescription drugs from Canada.  FDA’s letter states: The reason that Canadian or…

…chains between the United States and Canada, as well as the integrated cattle supply chain between the United States and Mexico, FSIS concluded that the better approach would be to…