News & Analysis as of

Manufacturers Supply Chain

Morgan Lewis

US Department of Justice Establishes Trade Fraud Task Force to Counter Tariff Evasion

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In late August 2025, the US Department of Justice announced the formation of a cross-agency Trade Fraud Task Force that will specialize in tariff-related investigations. DOJ positioned the new task force as an extension of...more

Willcox & Savage

Unlocking Hampton Roads - August 2025

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As the demand for strategically located, high-quality industrial real estate increases, Suffolk, Virginia, continues to grow as a key logistics and manufacturing center. With its close proximity to the Port of Virginia,...more

Goodwin

European Biosimilar Updates - Alvotech/Advanz’s MYNZEPLI Approval and Bio-Thera/STADA Tocilizumab Alliance

Goodwin on

On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more

Spilman Thomas & Battle, PLLC

Technology Law Insights, V 6, Issue 8, 2025

Welcome to our eighth issue of 2025 of Decoded - our technology law insights e-newsletter. Cybersecurity Ranks Among Top Three Risks to Manufacturing Sector - “Most companies are planning major AI investments to address...more

Arnall Golden Gregory LLP

Made in America? What Developers Need to Know About U.S. Supplement Facilities

Introduction - “Made in America” has strong consumer appeal, but in the dietary supplement industry, reality is far more complex. Roughly 75-80% of raw nutraceutical ingredients (like vitamin C, fish oils, amino acids, and...more

WilmerHale

Building an American Foothold: How Recent ITC Cases Create New Pathways for Domestic Production

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For companies looking to bring production back to American soil or start a new business, two recent cases at the US International Trade Commission (ITC or the Commission) have shed light on an existing but rarely used tool...more

Foley & Lardner LLP

Protecting Trade Secrets and Confidential Information in Global Supply Chains: Legal Strategies for Manufacturers

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In the era of globalization, companies are increasingly reliant on complex international supply chains to design, manufacture, and distribute their products. These extended partnerships—with contract manufacturers, component...more

Ice Miller

Capital Sources for Large-Scale Manufacturing and Infrastructure Projects

Ice Miller on

Businesses pursuing large-scale manufacturing and infrastructure investments—whether companies in the United States building new domestic facilities or foreign businesses expanding into the United States—can access a diverse...more

Arnall Golden Gregory LLP

“Back in the U.S.A.”: FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing

Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck...more

BCLP

What is the European Accessibility Act and What Impact Will It Have on Your Business?

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The European Accessibility Act (EAA) came into force on 28 June 2025. It requires that all in-scope products and services placed on the market or provided after that date in the EU must meet specified accessibility...more

Paul Hastings LLP

White House and DoD Unleash New Directives on Drones

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The White House and Department of Defense (DoD) have announced a series of new directives that will significantly impact the burgeoning domestic drone industry. This initiative, titled “Unleashing American Drone Dominance,”...more

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

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On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Foley & Lardner LLP

What Every Multinational Should Know About … the Use of Reshoring to Navigate Tariff Uncertainty

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The global manufacturing landscape is undergoing a fundamental shift. In recent years, reshoring — at times discussed more conceptually than executed in practice — has evolved into a strategic response to a range of complex...more

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Hogan Lovells

The digital makeover of EU product legislation

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The European Commission unveiled in May the fourth Omnibus package (“Omnibus IV”), part of its broader Single Market Strategy to modernise and simplify EU product legislation in line with the digital age. Omnibus IV aims to...more

Barnea Jaffa Lande & Co.

European Commission Tightens Law Enforcement on Pharmaceutical Cartels

In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...more

Shipman & Goodwin LLP

AI in the Factory: What Manufacturers Must Consider

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As generative artificial intelligence and machine learning continue their rapid rise in popularity and uses in business operations, manufacturers are faced with how to implement AI in a manner that allows them to take...more

Hinch Newman LLP

Essential Guide to FTC Made in USA Advertising Do’s and Don’ts | FTC Made in USA Attorney

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The Federal Trade Commission recently enacted the Made in USA Labeling Rule and updated its “Complying with the Made in USA Standard” business guidance. Both reinforce the “all or virtually all” standard...more

Goodwin

European Biosimilar Updates - Formycon’s Ustekinumab and Alvotech’s Cetrolizumab Pegol

Goodwin on

On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina...more

Arnall Golden Gregory LLP

On Demand, On Purpose: Fashion Manufacturing That Doesn’t Cost the Earth

In this episode, Allison Raley, AGG’s Women in Tech Law co-chair, is joined by Tia Robinson, TEDx speaker and founder of Vertical Activewear, to discuss how mindfulness, sustainability, and innovation are shaping the fashion...more

Davis Wright Tremaine LLP

Stars, Stripes, and Substantiation: The Boom in "Made in USA" Claims—and Lawsuits

Red, white, and booming: "Made in USA" advertising is having a moment. Brands across industries are leaning into patriotic themes, tapping into consumer enthusiasm for American-made goods, domestic job creation, and a good...more

Hogan Lovells

Securing supply in disruptive times – Ways to set up and adapt strategic sourcing agreements

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Driven by transformation trends and geopolitical volatilities, companies must reshape their sourcing strategies. Across all manufacturing sectors the focus is shifting towards securing access to vital technologies and scarce...more

BCLP

Minnesota Delays PFAS Reporting Deadline Six Months to July 1, 2026

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On July 23, 2025, the Minnesota Pollution Control Agency (MPCA) announced that it will allow manufacturers an additional six months to report required PFAS information, extending the original January 1, 2026, deadline to July...more

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