News & Analysis as of

Supply Chain Manufacturers

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

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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

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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

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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

DLA Piper

Industrials Regulatory News and Trends - July 2025 #2

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Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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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

Foley & Lardner LLP

Foley Automotive Update - July 2025 #2

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Foley is here to help you through all aspects of rethinking your long-term business strategies, investments, partnerships, and technology...more

Bergeson & Campbell, P.C.

DOD Publishes 2025 Update on Critical PFAS Uses, Recommends Risk-Based Approach to Defining PFAS

The U.S. Department of Defense (DOD) has published a July 2025 report entitled Update on Critical Per- and Polyfluoroalkyl Substance Uses. House Report 118-121, which accompanied the 2024 DOD appropriations bill (H.R. 4365),...more

Clark Hill PLC

3 key steps before signing a manufacturing NDA in China

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If your company is working with Chinese manufacturers to produce goods or prototypes, you’ve likely encountered a non-disclosure agreement (NDA) along the way. But many companies don’t realize that standard U.S. NDAs are...more

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Holland & Knight LLP

California's Microplastics Proposal: Impacts on the Consumer Products Supply Chain: The Proposed Listing of Microplastics Reflects...

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California's Department of Toxic Substances Control (DTSC) has proposed listing microplastics on its "Candidate Chemicals List" under the Safer Consumer Products (SCP) Program, a regulatory framework designed to reduce toxic...more

Pillsbury Winthrop Shaw Pittman LLP

Plasticizer PIP (3:1) Ban Is Still a Year Away, but Affected Companies Should Act Today

After October 31, 2026, the distribution in commerce of articles containing PIP (3:1) will be prohibited. Affected companies must phase out the production of PIP (3:1) articles and sell or otherwise remove current inventory....more

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