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Last week, the U.S. House of Representatives passed H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2008. The bill, which,…
By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had…
…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…
…certiorari in Merck & Co., Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket Nos. 12-245) and Upsher-Smith Laboratories, Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket No. 12-265) concerning K-DUR…
…not only here in the United States, but, for example, in Canada as well. In addition to Opana ER, FDA has received several citizen petitions (Docket Nos. FDA-2011-P-0473, FDA-2010-P-0540, and…
…Petition, requesting that FSIS limit the Product of USA claims to products made from beef from cattle born, raised, and harvested in the United States. On March 27, 2020, FSIS…
…proactive approach and sued Apotex and Roxane, saying, among other things, that “Apotex and Roxane are seeking to force Actelion to supply them with product, turning well-settled law, not to…
…16, 2019, the Center for Food Safety (CFS, endorsed by The Cornucopia Institute, Food & Water Watch, Cultivate Oregon, Maine Organic Farmers and Gardeners Association, Maine Organic Farmers and Gardeners,…
…annual summary of agreements filed with the Commission during Fiscal Year 2010 – “Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of…
…Grain Meat Co., Finless Foods, Hungry Planet, Impossible Foods, Lightlife, Sweet Earth Enlightened Foods and the Tofurky Company (collectively GFI) also oppose the USCA Petition. GFI’s comments focus primarily on…
…briefs for all parties are available here, here, here, and here. PREVOR was represented by Hyman, Phelps & McNamara, P.C. (attorneys Jeffrey N. Gibbs, John R. Fleder, Jennifer M. Thomas,…
…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…
…regulations for beef, pork, and poultry products requiring identification of the country where the animals are born, raised and slaughtered and preventing commingling. The amended COOL regulations were issued in…
…ends at close of business on Dec. 20, 2013. Our competition in the “Torts” category includes Drug and Device Law blog, Overlawyered, Litigation & Trial, and Abnormal Use. REMINDER: You can…
…regulating cigar “flavors” is fraught with uncertainty, and advocated for more specific guidance. For example, like wine, differences in cultivation, aging, and blending techniques result in cigars with distinctive flavor…