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,…

…as AI/ML. Ms. Torres also shared that the eSTAR program, which we most recently blogged about here, is being developed with Health Canada. The goal is to permit sponsors to…

…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…

…emerging new guidances and ongoing global efforts to root out NDSRIs. In addition to the FDA’s efforts, agencies in the E.U., Canada, Australia, and Malaysia have also recently updated their…

…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 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….

…reimport drugs from Canada, and Sen. Jim DeMint’s (R-SC) Amendment No. 763 to prevent FDA from using funding to phase out by 2012 OTC epinephrine metered dose inhalers that contain…

…thiopental are inconsistent with FDA’s regulations, procedures, and established practice.  As an example, the plaintiffs point to recent cases where states attempted to import foreign drugs from Canada and FDA…

…animals in the Netherlands, Canada, Denmark, and the European Union (EU). The programs in those countries and in the EU have resulted in a reduction in the use or sales…

…in another Illinois District Court Hatch-Waxman case involving generic FOSRENOL (lanthanum carbonate) 500 mg, 750 mg, and 1000 mg Chewable Tablets – Shire Canada Inc. v. Alkem Laboratories, Ltd., Case…

…however, ultimately will depend on the WTO decision.  The rumor is that the WTO has ruled on the fair trade challenge filed against COOL by Mexico and Canada and that…

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…

…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…

…from seven different countries (Canada, China, Hong Kong, Hungary, India, Italy, and Japan), the breakdown of countries placed on the list due to import refusals skews heavily to Chinese and…

…a well-controlled and consistent manner; and (iii) that data comparing European Union (EU)-approved Remicade EU)-approved to Inflectra could be used to show biosimilarity to US-licensed Remicade. A single dose PK…