2016

When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement,…

In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity…

Thanks to an increase in experienced compliance officers, settlements and court judgments between pharmaceutical manufacturers and…

The former Chief Executive Officer and Vice President of Sales of Acclarent, Inc., a medical device company and division of…

Corporate Integrity Agreement (CIAs) are a tool commonly employed by the HHS OIG to resolve healthcare fraud issues. This article…

FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members…

On August 2, 2016, at 1:30 pm EST, the Centers for Medicare & Medicaid Services (CMS) Open Payments Program will…

On July 20, 2016, CMS released a report that showed investments that are made in program integrity activities – such as…

In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO…

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) through its Innovation Center (CMMI) released a…