On May 19, 2025, the US Department of Justice announced the establishment of the Civil Rights Fraud Initiative, which will “utilize the False Claims Act to investigate and, as appropriate, pursue claims against any recipient...more
The US Department of Justice announced the establishment of the Civil Rights Fraud Initiative on May 19, 2025, which will “utilize the False Claims Act to investigate and, as appropriate, pursue claims against any recipient...more
The US Department of Justice on May 12, 2025 announced revisions to the Criminal Division’s “enforcement priorities and policies for prosecuting corporate and white-collar crimes” under the current US administration. The new...more
In its updated guidance issued on Tuesday, the US Department of Justice Criminal Division places effectiveness at the epicenter of its factors to be utilized when evaluating a company’s compliance program in the context of a...more
In recent remarks, AAG Brian A. Benczkowski emphasized that the US Department of Justice remains serious about fighting corporate fraud and corruption, and noted that transparency in its criteria for prosecution is a key tool...more
FDA agrees to allow truthful and non-misleading off-label promotion.
On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....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
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs