Protect Yourself and Your Business with Indemnification Understanding
False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
Data Driven Compliance: The Failure to Prevent Fraud Offense: Insights for US General Counsels with Mike DeBernardis
AI Today in 5: August 22, 2025, The Angst Episode
The Privacy Insider Podcast Episode 17: Security, Cyber-Intel, and a Sense of Humor with Nir Rothenberg of Rapyd
Demystifying Wage and Hour Audits: One-on-One with Courtney McFate
Compliance Tip of the Day: Using AI to Embed Your Compliance Program
Daily Compliance News: August 22, 2025, The WADA Returns Edition
Culture Crafters: Building a Culture of Accountability in the Face of Disasters
The Daunting Task of Export Compliance With Braumiller Law Group
New FLSA Notice Standard, DOL’s PAID Program, Axed Wage and Hour Penalties - #WorkforceWednesday® - Employment Law This Week®
Cuando la marca viaja en turista y sin registro
Compliance Tip of the Day: Trust and Verify
Great Woman in Compliance: Building Strategic and Effective Risk Assessments
Compliance into the Weeds: The Dark Side of AI in Employee Training
Compliance Tip of the Day: AI Assistant for Compliance
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
Daily Compliance News: August 19, 2025, The AI Winter Edition
FCPA Compliance Report: Accountability in Times of Crisis: A Conversation with Tom Fox and Sam Silverstein
AI Today in 5: August 18, 2025, The AI Music Episode
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more
As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more
In the December Public Company Watch, we cover key issues impacting public companies, including a preview of the SEC’s latest regulatory agenda, an update regarding the Fifth Circuit vacating the SEC’s share repurchase rules,...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
In part one of this series, I detailed how the U.S. Department of Justice has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. See “Part One: DOJ Devotes Resources, Vows to Come...more
An exploration of risk forecasting, risk assessment and risk-based monitoring for the compliance profession. ...more
This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more