Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...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