…from Abbott Point of Care in Ottawa, Canada.  “We all have access to similar information from the government (e.g., FDA draft guidances, etc.) but this blog not only explains the…

In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising…

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,…

…(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…

…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…

…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.”…

…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]…

…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…

…a citizen petition originally submitted in 2013 by anti-tobacco and public health groups (including prominent African American groups like the African American Tobacco Control Leadership Council) on prohibiting menthol cigarettes….