Compliance Tip of the Day: Why Engage in Pre-acquisition Due Diligence
Compliance Tip of the Day: Bringing Predictive Analytics into Your Compliance Regime
Compliance into the Weeds: Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 2 - Risk Assessment
FCPA Compliance Report: Fraud Risk Management - Insights and Experiences with Peter Schablik
#Risk New York Speaker Series – Inside Behavioral Insights: Tom Hardin on Compliance at #RiskNYC
Compliance Tip of the Day: COSO Framework
#Risk New York Speaker Series: Exploring AI Risks in Compliance with Gwen Hassan
Healthcare Enterprise Risk Management
Compliance Tip of the Day: Assessing Internal Controls in International Operations
Managing Sanctions Compliance
Regulatory Ramblings: Episode 68 - Why Geopolitical Risk Matters to Compliance and Legal Staff with Mark Nuttal and Chad Olsen
FCPA Compliance Report: Amanda Carty on a Due Diligence and Risk Management
Episode 364 -- Five Strategies to Mitigate a New Risk Environment
Strengthening Compliance: Lessons From the OCC's Consent Order With Patriot Bank — Payments Pros – The Payments Law Podcast
Compliance and AI: Ali Khan on Implementing AI Risk Management Systems
Compliance Tip of the Day: Superforecasting
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
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
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
On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more
Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more
FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more
FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs - On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more
Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more
TSCA/FIFRA/TRI - Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the...more
In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more
On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more