Innovation in Compliance: Operationalizing Trust at Scale: A Conversation with Amanda Carty on Compliance and AI
AI Today in 5: August 7, 2025. The US v. China Episode
Taxing Intelligence: AI's Role in Modern Tax Administration
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Compliance Tip of the Day: AI, Whistleblowing and a Culture of Speak Up
Podcast - Regulating AI in Healthcare: The Road Ahead
2 Gurus Talk Compliance: Episode 56 – The Grasshopper Edition
From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
Data Driven Compliance: Understanding the ECCTA and Its Impact on Fraud Prevention with Vince Walden
Daily Compliance News: August 1, 2025, The All AI Edition
AI and the False Claims Act
Innovation in Compliance: The Future of Compliance Training: AI, Adaptive, Learning, and Cultural
Compliance Tip of the Day: AI, Continuous Monitoring and Compliance
Everything Compliance: Episode 158, The No to Corruption in Ukraine Edition
Key Discovery Points: Detecting AI is Difficult and Tricky!
Compliance Tip of the Day: AI and 3rd Party Risk Management
[LEGAL MARKETING MOMENTS] A Simple Tip to Master Generative AI Prompts
Compliance Tip of the Day: Bringing Predictive Analytics into Your Compliance Regime
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...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
Heading into 2024, expectations for biotech venture capital (VC) and private equity (PE) investments were low following two lackluster years, but as we wrap up Q1, those expectations have been turned on their head after a...more
The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more
For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of currencies in both South American nations....more