11/30/11
The (VCSP) provides employers partial relief from past federal employment tax obligations related to workers voluntarily reclassified from independent contractors … Learn More →
11/29/11
On November 4, 2011, Hill Dermaceuticals, Inc. (Hill), a Florida-based drug manufacturer, sued the U.S. Food and Drug Administration (FDA). … Learn More →
11/28/11
On November 3, 2011, the U.S. Court of Appeals for the Tenth Circuit affirmed the findings of the District of … Learn More →
11/28/11
On November 9, 2011, the U.S. Food and Drug Administration (FDA) published “SOP: Decision Authority for Additional or Changed Data … Learn More →
11/28/11
On November 18, 2011, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the approval of the … Learn More →
11/23/11
On November 10, 2011, the U.S. Food and Drug Administration (FDA) announced its approval of the first blood product derived from cord blood indicated for treatment as a stem cell therapy. HEMACORD, the hematopoietic progenitor cell-cord (HPC-C) blood product, is intended for use in HPC transplant procedures for individuals affected with various blood disorders. Learn More →
11/23/11
On November 4, 2011, a Bill was introduced before the U.S. House of Representatives that proposes to restrict the definition of “new dietary ingredient” (NDI) under the Federal Food, Drug and Cosmetic Act (FDCA). Introduced by Representative Dan Burton, the “Dietary Supplement Protection Act of 2011” seeks to alter the current definition of NDI by changing the applicable dates for which a dietary ingredient must have previously been marketed in the United States. Learn More →
11/23/11
On November 18, 2011, the World Trade Organization (WTO) published its report on the ongoing Country of Origin Labeling (COOL) dispute. Implemented in 2008 as part of the Farm Bill, U.S. manufacturers began requiring country-of-origin to be designated in labeling of meats and other goods regulated by the U.S. Department of Agriculture (USDA). Found here, the WTO report details the complaints raised by Canada and Mexico, including the contention that the labeling requirements constitute Technical Barriers to Trade (TBT), in violation of international treaties between the countries. Learn More →
11/23/11
On November 11, 2011, the U.S. Food and Drug Administration (FDA) appealed a recent decision issued by the District Court for the Middle District of Florida, finding that the FDA lacked the authority to prohibit state-licensed veterinary compounding. The September 12, 2011 decision being appealed details the longstanding practice of pharmacy compounding in the context of veterinary medicine. Learn More →
11/22/11
On November 15, 2011, Zuffa, LLC, which owns the Ultimate Fighting Championship (“UFC”) brought suit against New York Attorney General … Learn More →