On June 22, 2012, the United States Court of Appeals for the District of Columbia Circuit affirmed that a partnership which utilized a Son of Boss tax shelter to […]
In late 2011, the U.S. Food and Drug Administration (“FDA“) launched an initiative targeting marketers of gastric band surgery following the death of five patients. The FDA is concerned that […]
On July 11, 2012, the Atlanta based Eleventh Circuit Court of Appeals issued its opinion in Shockley v. IRS, __ F.3d ____, (11th Cir.) available here, and overruled the U.S. […]
On July 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (“the Guidance”). The […]
As we previously reported, in September 27, 2010, the Federal Trade Commission (“FTC“) filed a complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false […]
On July 16, 2012, the =Senate Permanent Subcommittee on Investigations released a 335 page report detailing numerous and sustained AML regulatory compliance deficiencies over the past decade at London headquartered […]
On July 5, 2012, K-V Pharmaceutical Company (“KV“) filed a complaint against the U.S. Food and Drug Administration (“FDA“) in the U.S. District Court for the District of Columbia regarding […]
On July 5, 2012, the U.S. Food and Drug Administration (FDA) announced its intent to take enforcement action against companies that manufacture and distribute certain unapproved drugs that contain oxycodone. […]
As required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the U.S. Food and Drug Administration (FDA) issued a proposed rule on July 3, 2012 to establish […]
According to recent reports presented by BioFlorida, biotechnology funding in Florida tripled in 2011 and the growth of new biotech and medical device companies in Florida outpaced the national average. […]
