Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more
Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more
Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more
Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more
This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more