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…the case. Hyman, Phelps & McNamara, P.C., represented one of the defendants in the case. In October 2006, FDA approved Schering’s New Drug Application (“NDA”) (#22-015) to switch the company’s…
…state laws from discriminating against interstate commerce, or favoring in-state commerce over out-of-state commerce. New York moved to dismiss each case on jurisdictional grounds under the Tax Injunction Act (TIA),…
…Inc. with a “retail location” in Rowland Heights, California, and I-Takashima, Inc., with a “retail location” in Irvine, California. Both were charged with violating the Federal Food, Drug, and Cosmetic…
…exception: Raw milk that is tested, state inspected, state regulated, carries a “government warning statement” and labeled for retail sale in one state may be transported to another state if…
…mg, as currently labeled, outweigh the benefits. Most importantly, CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, may cause a number of adverse reactions, the most serious being bone marrow depression (anemia, thrombocytopenia,…
…appointed. For seven years, this compliance auditor has the “duty and responsibility to diligently and competently review, assess, and evaluate Defendants’ compliance with [various] provisions” of the consent decree and…
…to commit adulteration under the Federal Food, Drug, and Cosmetic Act (“FDC Act”). Based on a complaint by Dr. Kaplan’s own medical assistants to the Nevada State Medical Board, FDA’s…
…Act of 2010 authorizes USDA to set nutritional standards for foods sold in schools, including vending machines, lunch lines, and school stores. Combating the problem from a different angle, Alabama’s State…
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
…resulting in the deaths of young beagles, pigs, monkeys, or other animals are unnecessary, unethical, and inhumane. Vanda argues that these types of studies should be the exception rather than…
…New York, Florida, and Washington, D.C. resulting in several deaths. The likelihood that a terrorist attack using Chemical, Biological, Radiological, or Nuclear (“CBRN”) substances might occur in the United States…
…the results. FDA was given authority to grant EUAs as part of the Project BioShield Act of 2004, which amended section 564 of the Federal Food, Drug, and Cosmetic Act…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…biodynamic farming, pasture-feeding of livestock, community-supported farms, honest and informative labeling, prepared parenting and nurturing therapies.” The Foundation has also been a staunch advocate www.realmilk.com for increased availability and consumption…
…TEA process consists of several steps, the eligibility determination, the filing determination, review of the safety and effectiveness data, preparation of a proposed rule, comment period, and preparation of a…