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…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…
…of Certiorari in Louisiana Wholesale Drug Co., Inc., et al. v. Bayer AG, et al. (Docket No. 10-762) concerning whether a patent settlement agreement involving manufacturers of Ciprofloxacin HCl (CIPRO)…
…(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…
…30 days. Comments submitted after April 13 are posted on regulations.gov. Meanwhile, in a March 28, 2018 letter to GAO, U.S. Rep. Rosa DeLauro, D-CT requested that GAO “investigate what…
…FDA, the agency currently lacks “express legal authority to compel” a company to provide such evidence. In its response to the report, FDA indicated that it will consider “whether additional…
…position that such operations are eligible for certification as long as they comply with the National Organic Program (NOP) regulations. Now, organic hydroponic agriculture is facing a new challenge. Between…
…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.”…
…not meet all of the requirements of the U.S. approval, and thus is considered to be unapproved. 21 U.S.C. § 355. The U.S. Senate Appropriations Committee, which passed its version…
…lung cancer incidence, and the uncertainty about the potentially negative consequences of an immediate menthol ban. . . .” H.R. Rep. No. 111-58, at 38-39 (2009). “Given the number of…
…regulation, includes Subtitle E, Drug Pricing. Subtitle E is a slightly modified version of H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act introduced by Representative Pallone on…
…oversee. Meanwhile, manufacturers are on the hunt to find their quarry before their customers do it for them. We’ll report back as this complex regulatory structure continues to take shape….
…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…
…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…
…FDA to recover and remove from interstate commerce all shipments of foreign thiopental that have been released into interstate commerce in the last 12 months. Thiopental, which was developed in…
…or playground area in a public park . . ., elementary school, or secondary school.” However FDA must issue a regulation “in light of governing First Amendment case law,” explaining…