On January 6, 2012, the U.S. Food and Drug Administration (“FDA”) denied a citizen petition (Docket No. FDA-2008-P-0291) requesting the FDA to require manufacturers and distributors of prescription drug products […]
After conducting inspections of American Red Cross facilities between April 2010 and October 2010, the FDA found that 16 blood collection sites did not meet the FDAs standards for safety. […]
On January 9, 2012, the Supreme Court heard oral argument in the case of Sackett v. United States Environmental Protection Agency. Although the facts of the case concern issues governed […]
On December 20, 2011, the U.S. Food and Drug Administration (FDA) published guidance entitled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” The guidance […]
Last month, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the issue of responding to unsolicited requests for information about off-label use of prescription drugs and […]
On January 9, 2012, the IRS reopened the Offshore Voluntary Disclosure Program (OVDP) following continued interest from taxpayers and tax practitioners after the closure of the 2011 and 2009 programs. […]
On December 31, 2011, President Barack Obama signed into law the National Defense Authorization Act. Among the various provisions included within the $662 billion defense spending bill are new sanctions […]
On December 2, 2011, the IRS issued Notice CC-2012-002, available here, setting forth the IRSs position “that a federal common law analysis to prove alter ego status is legally correct […]
On January 3, 2012, a grand jury sitting in the Southern District of New York returned an indictment charging Michael Berlinka, Urs Frei, and Roger Keller with conspiracy to defraud […]
On November 8, 2011, a grand jury sitting in the U.S. Virgin Islands returned a second superseding indictment in the case of United States of America and People of the […]
