Moving Beyond the Usual Helpline Data
Compliance Tip of the Day: Why Engage in Pre-acquisition Due Diligence
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
Hill Country Authors – Exploring the Challenges of a Green Transition with Tom Ortiz
Taxing Intelligence: AI's Role in Modern Tax Administration
LathamTECH in Focus: Move Fast, Stay Compliant
AI Today in 5: August 6, 2025, The Rethinking Compliance Episode
Daily Compliance News: August 6, 2025, The Spanking Banks Edition
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Compliance Tip of the Day: M&A – International Issues
From Forest to Fortune: Navigating Workplace Ethics With Robin Hood — Hiring to Firing Podcast
Under the Radar: DOJ's Data Security Rules and Their Impact on Payments Companies — Payments Pros – The Payments Law Podcast
Adventures in Compliance: The Novels - The Valley of Fear, Introduction and Compliance Lessons Learned
Episode 381 -- NAVEX's 2025 Annual Hotline Report
12 O’Clock High, a podcast on business leadership: Building Trust and Relationships: The Power of Compliance and Ethics with Jacqui Pruet
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
Compliance Tip of the Day: AI, Continuous Monitoring and Compliance
Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more
On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments....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
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally....more
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more
On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more
On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025. By way of brief background, FDA designed the HFP to...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
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
With distribution of COVID-19 vaccines moving ahead full-steam, an end to the pandemic may be in sight in the coming months. However, what is collectively known as the “new normal” still comes with a minefield of unanswered...more
As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans. As a result...more
...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has been documented in six of the world’s seven continents (sparing only Antarctica), in more than 70 countries and territories. More...more
The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented. Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic. The US...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has...more
On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more
On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more