Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more
In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...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
In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...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