Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
Podcast - The CFPB's Proposal to Create a Public Registry
Breaking Mindsets with Sharon Sorkin from Ford on Being Reliably Transparent
Auditing and Monitoring in Healthcare
Exploring The ‘S’ In ESG & What To Expect In 2023
The Line Between Gift Giving and Bribery
The New Cold War: Risk, Sanctions, Compliance Episode 21: "Interview with Drago Kos of the OECD Working Group on Bribery"
ABA Sound Advice: Conducting Civil Rights Audits: Benefits and Best Practices
Early Advocates of Organic Food Products, Amy’s Kitchen Believes in the Benefits of a Fully Regenerative Ecosystem and Aims to Help Heal the Planet Through Its Business
AI, Analytics, and the Benefits of Transparency
Life With GDPR: Episode 50-The Experian Enforcement Notice Case
Scrutiny Increasing On Energy Private Equity Valuation
Compliance Perspectives: Supply Chain Compliance Challenges
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more
Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more