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Podcast - “I Lied Like a Dog!”
Sittenfeld v. United States – Campaign Contributions as Crimes?
Podcast - Persistence and Determination
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
10 For 10: Top Compliance Stories For the Week Ending, July 12, 2025
RICO Section 1962(b): Acquisition or Maintenance of Control Over Legitimate Enterprises — RICO Report Podcast
Podcast - The Seeds of Corruption
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Daily Compliance News: June 16, 2025, The Golden Share Edition
The JustPod: Defending the "Evil Genius:" A Conversation with Leonard Ambrose
The Presumption of Innocence Podcast: Episode 62 - The Tragic Toll of Conspiracy Theories: The Seth Rich Story
SBR-Author’s Podcast: The Unseen Life of an Undercover Agent: A Conversation with Charlie Spillers
Podcast - "Ready for Trial?"
Podcast - The Law as a Force for Change
The JustPod: A Discussion with Defense Counsel Rocco Cipparone and Angie Levy on January 6 Prosecutions
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
The JustPod: A murder-for-hire allegation, public corruption trial, and notable acquittal
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more
In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
In Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more
LEGISLATION, REGULATIONS & STANDARDS - House Passes Cannabis Banking Bill - The U.S. House of Representatives has passed the SAFE Banking Act, which allows financial-service firms to work with “cannabis-related...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
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more