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…Necessary to Compete), Section 56:9-4 of the New Jersey Antitrust Act, and New Jersey Common Law (Unfair Competition and Tortious Interference with an Economic Advantage). Judge Salas, however, also dismissed…
…titled “A Bill to Revise, Codify, and Enact Into Law, Title 21, of the United States Code, Entitled ‘Food, Drugs, and Cosmetics.’” The House and Senate Reports of the bill…
…In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set in United States v. Dotterweich, 320 U.S. 277 (1943), and United States v. Park,…
…on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to discuss in an Executive Session various pieces of FDA legislation. Among those pieces of legislation—all intended to shield FDA…
…come off the market. Phibro holds the three NADAs at issue here, and the company, unsurprisingly, vehemently disagrees with FDA. In its whopping 70-page complaint. Phibro is asking for judicial…
…Energy and Commerce Committee’s discussion document: Over the course of the last year, patients, providers, innovators, regulators, and researchers from around the country have provided a wide range of specific…
…performance standards for Salmonella on beef carcasses, ground beef, pork carcasses, chicken carcasses and parts, comminuted chicken, turkey carcasses, and comminuted turkey. FSIS also developed performance standards for Campylobacter on…
…are all animals other than the 7 major species (dogs, cats, cattle, horses, swine, chickens, and turkeys). The Act was intended to increase drug availability by modifying the Federal Food, Drug,…
…to foods comprised of or containing cultured seafood cells, what attributes (such as nutrition, taste, texture, or aroma) vary between the foods and should FDA consider to be material to…
As readers of this blog may recall, the issue of the regulation of meat and poultry derived from cell lines, identified by such terms as cultured meat, clean meat, and…
…Policy Book. In support of its petition, USCA discusses the definition of “meat” and “beef” in common dictionaries and by USDA, the Federal Trade Commission’s (FTC’s) truth in advertising standard,…
…the regulatory review period, in which the company argued that August 8, 1995 is the controlling date for PTE purposes. On May 7, 2008, FDA denied Wyeth’s request. FDA’s letter…
…as “equal to or less than 50,000 horses; 70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 turkeys; and 72,000,000 chickens.” In the Federal Register notice announcing the final rule,…
…antimicrobial drugs in animals. See 73 Fed. Reg. 38110 (July 3, 2008). However, after extending the comment period, and receiving numerous substantive comments, only few of which supported the order,…
…include muscle cuts of beef (including veal), lamb, chicken, goat, and pork; ground beef, ground lamb, ground chicken, ground goat, and ground pork; wild and farm-raised fish and shellfish; perishable…