Life Science Compliance Update

Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in…

The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and…

In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol- Myers Squibb in…

Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance…

As part of the process of entering into civil and criminal settlement negotiations with the government resulting from allegations…

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had…

Arizona was the first state to bite the bullet and allow pharmaceutical companies to communicate off-label uses of their drugs to…

Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label…

On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time,…

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether…