Great Woman in Compliance: Building Strategic and Effective Risk Assessments
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
Compliance Tip of the Day: Finance Models for Compliance
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
The U.S. Environmental Protection Agency (EPA) announced on August 11, 2025, the results of process improvements to accelerate the review of Low Volume Exemptions (LVE) in the Toxic Substances Control Act (TSCA) New Chemicals...more
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
On July 24, 2025, U.S. Environmental Protection Agency (EPA) approved a Test Marketing Exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) for a confidential new chemical substance (TME...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
The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more
AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more
On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the...more
On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...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 May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more
The U.S. Toxic Substances Control Act (TSCA) plays a critical role in regulating chemicals to safeguard human health and the environment. Its 2016 amendment expanded the U.S. Environmental Protection Agency’s (EPA's)...more
The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...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
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...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
On December 31, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on the preliminary lists of manufacturers (including importers) subject to fees for the next five...more
Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more
On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances...more
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
The U.S. Environmental Protection Agency (EPA) concluded its risk evaluation of 1,4-Dioxane under the Toxic Substances Control Act (TSCA) and issued a Notice of Availability of its Final Supplement to the Risk Evaluation and...more
Companies using formaldehyde in their manufacturing processes and/or selling products incorporating formaldehyde-containing components from upstream suppliers face significant challenges in an evolving regulatory landscape....more
Section 6 of the Toxic Substances Control Act (TSCA) requires an assessment of unreasonable risk to “potentially exposed or susceptible subpopulations” (PESS) in high-priority substance risk evaluations. Wiley is partnering...more
If you’re a government contractor in the manufacturing industry looking to buy or sell your business, there are specific concerns you should be aware of to protect your interests. This webinar will guide you through legal and...more
The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more