Thoughtful Insight and Updates on Legal Issues that Matter to You

Perspectives

Money Laundering charges now require proof that a transaction has the purpose of concealing illegal monies

Recently two cases involving the amount of proof required to sustain criminal convictions for money laundering were decided before the United States Court of Appeals for the Sixth Circuit, based […]

When Export “Classification Determinations” do not Determine Anything At All

In the August 2, 2010 edition of the Federal Register, the Bureau of Industry and Security (BIS) “ the Department of Commerces group in charge of export regulation in that […]

FDA Clears First Embryonic Stem Cell Trial Using Patients to Begin

The U.S. Food and Drug Administration (FDA) has given the “go ahead” to the worlds first authorized human trial of a treatment derived from human embryonic stem cells.  This trial […]

HSBC is New Target of DOJ Investigation into International Banks and Tax Evasion

The next bank to draw the attention of the Internal Revenue Service (IRS) after the UBS investigation, on which we previously reported, is London-based HSBC.  The Department of Justice (DOJ) […]

FDA approves generic Lovenox® (enoxaparin) representing a major policy advancement for naturally-sourced generic drugs and possibly biosimilars.

On July 23, 2010 the FDA approved the first generic enoxaparin product in a major policy advancement that will likely impact a number of other naturally sourced generic drugs and […]

FDA Issues Notice for Voluntary Registration for Non-Covered Retail Food Establishments and Vending Machine Operators Electing to Opt-In to Coverage of the Nutritional Disclosure Requirements of the Patient Protection and Affordable Care Act of 2010

As we previously reported, the Patient Protection and Affordable Care Act of 2010 (“PPACA”) contains a section requiring nutritional disclosure requirements for certain retail food establishments and vending machine operators. […]

New Physician Gift and Disclosure Reporting Rules that Drug and Medical Device Manufacturers Should Know

Drug and medical device manufacturers need to be aware and comply with state and federal gift disclosure rules because a failure to comply, even if inadvertent, could mean hefty monetary […]

Tax Dodgers Beware: New Foreign Account Tax Compliance Legislation

The Foreign Account Tax Compliance ACT (FATCA) is Congresss newest attempt to tackle tax evasion, specifically that which occurs through the utilization of offshore accounts.  Nearly all provisions of the […]

DC Circuit Court Allows “Rivals” in Research who are Competing for Federal Grants to Challenge Agency Actions that Benefit Their Opposition

On June 25, 2010, the United States Court of Appeals for the District of Columbia Circuit issued an opinion holding that two doctors who were applying to the National Institute […]

Medicare Fraud of $251 Million, 94 Suspects Indicted

On Friday, July 16, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced that the joint DOJ-HHS Medicare Fraud Strike Force has charged 94 people […]