FDA Publishes “First-of-a-Kind” Guidance for Medical Device Premarket Approval and De Novo Decisions
On March 27, 2012, the U.S. Food and Drug Administration (“FDA”) published a “first-of-a-kind” guidance document for industry and FDA … Learn More
On March 27, 2012, the U.S. Food and Drug Administration (“FDA”) published a “first-of-a-kind” guidance document for industry and FDA … Learn More
The IRS has recently gone on a hiring spree, bringing on board personnel with expertise in law, accounting, and economics, … Learn More
On March 21, 2012, the Supreme Court of the United States issued its opinion in the case of Sackett v. … Learn More
As we previously reported, the Food and Drug Administration (“FDA”) released a Draft Guidance for Industry entitled, “Dietary Supplements: New … Learn More
After nine years of ongoing litigation, on February 23, 2012, the U.S. District Court for the Northern District of Connecticut … Learn More
The FDA has made clear that prosecuting individuals for strict liability misdemeanors under the Park Doctrine, also known as the … Learn More
On March 19, 2012, a panel of the U.S. Court of Appeals for the Third Circuit reversed the Tax Court … Learn More
On March 19, 2012, Judge Jacobs in speaking for the Unitd States Tax Court ruled that a United States Virgin … Learn More
On March 16, 2012, the Financial Crimes Enforcement Network (“FinCEN”) of the United States Department of the Treasury issued a … Learn More
Food and dietary supplement manufacturers should be cautioned about the recent rise in consumer litigation. Over the past several years, … Learn More