Today, the 8th Circuit Court of Appeals reversed and remanded, in a published and precedential opinion, a decision of the Tax Court in Coffey v. Commissioner, (8th Cir., case # […]
On November 22, 2011, the U.S. Food and Drug Administration (FDA) published a Warning Letter to Mylan, Inc. Found here, the October 13, 2011 Warning Letter cites Mylan for “significant […]
On November 4, 2011, two New Jersey attorneys, Goldie Sommer and Edward Engelhart, were charged with conspiring to violate and violating the Bank Secrecy Acts (“BSA”) by “structuring” attorney trust […]
The (VCSP) provides employers partial relief from past federal employment tax obligations related to workers voluntarily reclassified from independent contractors to employees. In its announcement of the program, the IRS […]
On November 4, 2011, Hill Dermaceuticals, Inc. (Hill), a Florida-based drug manufacturer, sued the U.S. Food and Drug Administration (FDA). Hill brought suit in connection with the FDAs recent approval […]
On November 3, 2011, the U.S. Court of Appeals for the Tenth Circuit affirmed the findings of the District of Wyoming, granting the dismissal of the lawsuit filed by Cody […]
On November 9, 2011, the U.S. Food and Drug Administration (FDA) published “SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions.” The document sets forth limitations to […]
On November 18, 2011, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the approval of the breast cancer indication for Avastin. Because Avastin will still be […]
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.
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.
