Episode 381 -- NAVEX's 2025 Annual Hotline Report
AI and the False Claims Act
Disparate Impact & Enforcement Rollbacks: What’s the Tea in L&E?
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
A New Brand of Uncertainty? — PE Pathways Podcast
The Rise of OTAs in Defense Contracting: Opportunities, Risks, and What Contractors Need to Know
Breaking the Cycle: Flooding, Infrastructure, and Climate Law in Practice
No Password Required: Former Lead Attorney at U.S. Cyber Command, Cyber Law Strategist, and Appreciator of ‘Mad Men’ Hats
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Beyond the Bylaws: The Medical Staff Show - Need to Know: How to Manage Medical Staff Confidentiality and Privilege Protections
False Claims Act Insights - The Mathematics of Nuclear FCA Verdicts
PODCAST: Williams Mullen's Benefits Companion - Cost, Care and Captives: A Mid-Size Employer’s Guide to Benefit Trends
Compliance Tip of the Day: Citibank and Continuous Monitoring
Lawyers Beware: There Could Be Serious Ethics Issues With The New AI Browsers
Compliance and AI: Navigating Risk Management in the AI Era with Gaurav Kapoor
Data Driven Compliance: Understanding the UK’s New Failure to Prevent Fraud Offense with Sam Tate
Avoiding a Bored Board
Compliance Tip of the Day: Crowd Sourcing Risk Intelligence
We get Privacy for work – Episode 6: The Potential Privacy Risks Inherent to Mergers and Acquisitions
The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...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
TSCA/FIFRA/TRI - EPA Issues Final Risk Management Rules For TCE, PCE, And CTC: The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for...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
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
On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The U.S. Food and Drug Administration (FDA) released its final rule on the traceability of high-risk foods on 21 November 2022. The regulations, to be codified at 21 C.F.R. part 1, subpart S (titled “Additional Traceability...more
TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more