Episode 381 -- Cadence Design Pays $140 Million to Settle Trade Violations
On Demand, On Purpose: Fashion Manufacturing That Doesn’t Cost the Earth
Compliance Tip of the Day: AI and 3rd Party Risk Management
All Things Investigations – Navigating Secondary Tariffs with Mike Huneke and Brent Carlson
FCPA Compliance Report: The Impact of Secondary Tariffs on Global Trade with Mike Huneke and Brent Carlson
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
GILTI Conscience Podcast | Beyond the Runway: Navigating Tax, Tariffs and Transfer Pricing in Luxury Fashion
How International Companies Can Prepare for July 9 Tariffs
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Hot Topics in International Trade - Tariff Mitigation Strategies
A Voltage Voyage With Danielle Spalding, Cirba Solutions — Battery + Storage Podcast
Compliance in the Former Soviet Central Asian Republics
Tariffs and Trade Series: What Boards of Directors Need to Know
Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
Tariffs and Trade Series: What Senior Management Teams Need to Know
Wiley's 2025 Key Trade Developments Series: Trade Remedies
Understanding Human Trafficking and Modern Slavery: A Business Imperative with Clint Palermo
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
The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more
In the dynamic world of life sciences, companies face unique challenges in safeguarding their valuable assets. From pharmaceuticals to biologics, medical devices to vaccines, these products often require specialized handling...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
Some Medtech companies recently addressed the potential impact of global tariffs in their Q1 2025 earnings calls. Johnson & Johnson and Abbott were among the first to speak on the implications of these tariffs and how their...more
How CDMOs are reshaping pharmaceutical partnerships through friendshoring, risk-sharing economics, and specialized development capabilities. The pharmaceutical manufacturing landscape is undergoing a profound shift, with...more
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more
In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more
China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more
It has been four months since the world learned of coronavirus disease 2019 (“COVID-19”), the new strain of coronavirus causing respiratory infection in its victims. With nearly 154,000 confirmed cases and a current death...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
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
On December 20, 2019, President Trump signed into law the National Defense Authorization Act for Fiscal Year 2020 (“NDAA 2020”), which includes numerous sanctions-related provisions. The law includes the previously introduced...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In...more
Change is coming to the life sciences industry. Price pressure, new market entrants, the emergence of personalized medicine, and even climate change are adding complexity to traditional manufacturing processes and supply...more