Compliance Amidst a Global Consensus Breakdown
Safeguarding Your Business Data
(Podcast) The Briefing: When a TikTok Costs You $150,000 - Copyright Pitfalls in Influencer Marketing
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Hot Topics in International Trade Terrified by Tariffs Braumiller Law
Tariffs and Trade Series: What Boards of Directors Need to Know
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Harnessing AI in Litigation: Techniques, Opportunities, and Risks – Speaking of Litigation Video Podcast
Strategies for Business Resilience in Uncertain Times
Podcast - Innovations and Insights in the Palliative Care Space
Daily Compliance News: May 16, 2025, The Ethics Nightmare Edition
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
Managing Sanctions Compliance
Regulatory Ramblings: Episode 69 - Human Intelligence vs. Machine Judgment with Nigel Morris-Cotterill and Patrick Dransfield
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Daily Compliance News: May 15, 2025, The Downfall in Davos Edition
Great Women in Compliance: The Compliance Influencer with Bettina Palazzo
Tariffs and Trade Series: What Senior Management Teams Need to Know
No Password Required: CEO of HACKERverse.ai, Disruptor of Cybersecurity Sales and Most Other Things
In the dynamic world of life sciences, companies face unique challenges in safeguarding their valuable assets. From pharmaceuticals to biologics, medical devices to vaccines, these products often require specialized handling...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more
AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more
Want to learn more about drafting, negotiating, and understanding intellectual property and technology contracts and have 10 minutes to spare? Grab your morning coffee or afternoon tea and dig into our Tech Contract Quick...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
This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
In this episode, Michael Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...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 March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...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
Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...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
This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...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
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...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
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the eighth episode of When Your Life Sciences Are on the...more
In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...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