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
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...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
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
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more
The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...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
In the past few weeks, the FDA has continued to focus its attention on supply chain issues. The agency published draft guidance on its verification system expectations of supply chain trading partners for prescription drugs...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more
Report on Supply Chain Compliance 3, no. 7 (April 2020) - The crippling severity the coronavirus outbreak has had on peoples’ daily lives and on the world’s economy is a direct result of a fragmented and thinly stretched...more
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. The purpose of the CARES Act is to provide emergency assistance and health care response for individuals, families, and...more
On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more
In the wake of combatting the COVID-19 pandemic, the German Federal Government is proposing to enable further measures on federal level. The proposal includes important measures concerning supply of medical devices,...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the purpose of which is to provide emergency assistance and health care responses for individuals,...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
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more