Illness, Disability, and Workplace Performance: A Guide for Employers
Episode 384 -- Third-Party Risks and Sanctions
Building a Team of Trusted Advisors
ERGs: Valuable or Vulnerable?
Navigating U.S.-China Relations: Lessons From History for Today’s Global Economy
Work This Way: A Labor & Employment Law Podcast | How Employers Can Protect Intellectual Property with Bryan Baysinger of Maynard Nexsen
Regulatory Rollback: Impact of the CFPB's Withdrawal of Overdraft and Deposit Account Fee Guidance on Financial Institutions and Related Litigation Risks — The Consumer Finance Podcast
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
Hot Topics in International Trade - 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
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more
This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...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
Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more
In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...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
Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic...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
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more
On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
Report on Patient Privacy 23, no. 12 (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...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
The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more