News & Analysis as of

Manufacturers

Mandelbaum Barrett PC

How Can Defective Product Liability Apply to Automotive Parts in New Jersey?

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When your car’s brakes fail on a busy New Jersey highway or your airbag doesn’t deploy during a collision, a defective automotive part may have caused your injuries rather than driver error. In these cases, defective product...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

Tucker Arensberg, P.C.

AI in the Workplace: Navigating the Legal Minefield in the Digital Gold Rush

Tucker Arensberg, P.C. on

Artificial intelligence is transforming the workplace — but the law is struggling to keep up. In industries like steel and manufacturing, where efficiency, safety, and workforce management are paramount, the adoption of AI...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

Fisher Phillips

Snapshot for Manufacturers: Delay Alone Can Violate the ADA

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Welcome to this edition of FP Snapshot for Manufacturers, where we take a quick snapshot look at a recent significant workplace law development with an emphasis on how it impacts employers in the manufacturing sector. This...more

K&L Gates LLP

Vermont's Agency of Natural Resources to Implement Nation's First Household Hazardous Waste Stewardship Program

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Vermont has become the first state in the nation to implement a household hazardous waste extended producer responsibility law. This is an important development for two key reasons....more

Baker Donelson

Countdown to Compliance: Packaging EPR Deadlines

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Extended Producer Responsibility (EPR) laws are reshaping packaging obligations for businesses across the United States. EPR regulations fundamentally shift the financial and operational burden of managing post-consumer...more

Ballard Spahr LLP

Key Trends Shaping Life Sciences IP Licensing

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The life sciences industry continues to evolve rapidly, driven by technological advancements, shifting economic conditions, and global market dynamics. As companies navigate this complex landscape, several key trends are...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

Robinson+Cole Health Law Diagnosis

HRSA Publishes 340B Rebate Pilot Program FAQs

As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2025 #2

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Goodwin

Lupin Announces Licensing Deal with Sandoz for Ranibizumab Biosimilar

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On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more

Ice Miller

Capital Sources for Large-Scale Manufacturing and Infrastructure Projects

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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

Nelson Mullins Riley & Scarborough LLP

FTC Advertising Compliance for Foreign Manufacturers Entering the U.S. Market

As your company prepares to enter the U.S. market, it is essential to understand and comply with the Federal Trade Commission’s (FTC) advertising and labeling regulations. These rules are designed to protect consumers from...more

Venable LLP

Accord Announces Launch of Stelara® (ustekinumab) Biosimilar Imuldosa®

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On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Imuldosa® is approved for all the reference product’s...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

Womble Bond Dickinson

A Guide for the Registration of Manufacturers and Distributors of Associated Equipment in Nevada

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Unlike the approval process for many aspects of Nevada gaming, manufacturers and distributors of associated equipment are not required to be found suitable or licensed by the Nevada Gaming Control Board (“Board”) and the...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Hogan Lovells

The new European Accessibility Act (EAA)

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The EAA (i.e., Directive (EU) 2019/882) aims at improving the accessibility of certain products and/or services across the EU. It seeks to harmonize accessibility requirements, ensuring that people with disabilities can fully...more

McDermott Will & Schulte

This Week in 340B: August 12 – 18, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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

Bass, Berry & Sims PLC

Manufacturing & Industrial: Outlook & Trends 8.19.25

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As the manufacturing sector continues to navigate a dynamic economic and regulatory landscape, the current environment presents both significant opportunities and complex challenges. From strong buyer demand in a competitive...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

Rumberger | Kirk

Proportionality in Practice: How Florida’s New Discovery Standard Reframes Product Liability Litigation

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In 2024, the Florida Supreme Court changed the Florida Rules of Civil Procedure, aligning them with federal standards in many areas. One of those areas was the scope of discovery. What was once an expansive often burdensome...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

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