On October 24, 2011, the United States Court of Appeals for the Second Circuit issued its decision in United States v. Banki overturning the conviction of Mahmoud Reza Banki for […]
On October 17, 2011, the Seventh Circuit Court of Appeals affirmed a district court ruling dismissing a state law consumer fraud claim, finding that it was preempted by the Federal […]
On October 25, 2011, the former president and the executive vice president of Terra Telecommunications Corp. (Terra) were sentenced in connection with their convictions at trial for money laundering and violating the Foreign Corrupt Practices Act (FCPA).
On June 7, 2011, Judge Foley in writing for the Tax Court held that corporate taxpayers cannot rely on the advice of a tax professional as a reasonable cause defense […]
In Woodsum v. Commission, 136 T.C. No. 129 (June 13, 2011), Judge Gustafson addressed the taxpayers’ petition for redetermination of accuracy-related penalty of $104,295 that the Internal Revenue Service (IRS) […]
On October 14, 2011, Representative Brian Bilbray introduced a bill before the U.S. House of Representatives, entitled the “Novel Device Regulatory Relief Act of 2011.” The Bill, which seeks to […]
On October 14, 2011, Par Pharmaceutical, Inc. (Par Pharma) brought suit against the U.S. Food and Drug Administration (FDA) challenging the Agencys rules that restrict claims made in marketing pharmaceutical […]
On October 14, 2011, Medisca, Inc. pled guilty to introducing a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). The Complaint, which was filed on October 14, alleged that Medisca purchased a drug called “Somatropin” from China and then proceeded to distribute the drug to various pharmacies throughout the United States.
An illustration of FDA’s increased powers, a recent seizure was the first directed by the FDA under the authorization of the Food Safety Modernization Act (FSMA). Specifically, on October 11, 2011, the U.S. Food and Drug Administration (FDA) announced that U.S. Marshals seized food products at the FDA’s request. The food, which was being held at a storage and processing facility in Washington, was originally detained due to an infestation found during a FDA inspection. After having ordered the detention of the food products on September 2, 2011, FDA sought a warrant for the arrest of the products in federal court, ultimately resulting in the seizure.
On October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced the official launch of the parallel review program. An effort to increase patient access to a variety of medical devices and drugs, the program is designed to facilitate the development of innovative medical products and reduce the time between FDA approval and CMS national coverage determinations.
