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
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
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the Daily Compliance News....more
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...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
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
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
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more
Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...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
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
On January 10, 2025, China’s State Administration for Market Regulation (SAMR) officially released the Compliance Guidelines on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (the Guidelines). This...more
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more
Like many companies in other sectors, Life Sciences companies recognize that corporate social responsibility (CSR)–evaluated and measured by independent rating organizations and based on their compliance with any applicable...more