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Manufacturers Risk Management

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...more

Hogan Lovells

AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.

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Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

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The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Vedder Price

Taking Off: Financing the eVTOL Revolution

Vedder Price on

Imagine waking up in a peaceful, spacious community free from traffic and congestion, yet commuting quickly and comfortably into the bustling city center or directly to the airport within minutes. Picture military operations...more

BakerHostetler

[Podcast] A New World: Indemnification, Artificial Intelligence and Intellectual Property

BakerHostetler on

To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Mandelbaum Barrett PC

Tariffs Expected to Impact Construction Costs

Mandelbaum Barrett PC on

The Impact of Tariffs on Construction Costs - As construction costs continue to soar, the industry is bracing for even sharper increases in 2025. Tariffs on key materials—iron, steel, and lumber—are expected to drive up...more

Fenwick & West LLP

Intellectual Property in Heavy Manufacturing

Fenwick & West LLP on

Heavy manufacturing companies operate at the intersection of hardware, materials science, and automation—sectors where IP protection is critical for long-term competitive advantage. Unlike software startups, industrial...more

Hahn Loeser & Parks LLP

Construction Contracts for Manufacturing Facilities

The Federal Government’s recent imposition of tariffs appears designed largely to bring manufacturing back inside the United States. News reports indicate the Government understands that tariffs may initially cause pain but...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Contradicts Benzene Class Actions, Highlighting Risks of Third-Party Lab Testing

In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

Amundsen Davis LLC on

The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

Robinson+Cole Manufacturing Law Blog

Here’s How Commercial Contracts Can Ease the Cost Burden of New Tariffs Impacting Manufacturers

Commercial contracts tend to be full of “boilerplate provisions” that, to paraphrase Mark Twain’s assessment of classic novels, everyone knows are important, but no one actually reads. When COVID-19 struck, manufacturers...more

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

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The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Waste Enforcement: Alabama Department of Environmental Management and Marshall County Specialty Tank Manufacturer Enter...

The Alabama Department of Environmental Management (“ADEM”) and Pinnacle Manufacturing, LLC (“Pinnacle”) entered into a March 5th Consent Order (“CO”) addressing alleged violations of the Alabama Hazardous Waste regulations....more

Beveridge & Diamond PC

Twelve TSCA Developments to Expect in 2025 (Updated)

Beveridge & Diamond PC on

This alert was originally published on December 4, 2024, and has been revised based on recent developments. With the election of Donald Trump, the implementation of the Toxic Substances Control Act (TSCA) in 2025 will...more

Blake, Cassels & Graydon LLP

Le Canada publie son rapport final sur l’état des substances perfluoroalkylées et polyfluoroalkylées

Introduction - Le gouvernement du Canada a annoncé son intention de désigner les substances perfluoroalkylées et polyfluoroalkylées (les « SPFA »), soit une famille de milliers de produits synthétiques connus pour leur...more

Blank Rome LLP

What Is DMSMS and What to Do About It?

Blank Rome LLP on

What does DMSMS mean? DMSMS stands for Diminishing Manufacturing Sources and Material Shortages. It is the loss or impending loss of manufacturers or suppliers of items, raw materials, or software. In other words, DMSMS...more

Baker Donelson

Top Five AI Procurement Questions General Counsel for Manufacturers Should Consider

Baker Donelson on

Artificial intelligence (AI) is reshaping the future of manufacturing. As manufacturing operations shift back to the U.S. in response to recent tariff policies, general counsels (GCs) in the manufacturing sector face a...more

Foley & Lardner LLP

Brainwaves: 100 Days and Beyond | Presidential Policy Shifts Impacting Automotive

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Share on Twitter Print Share by Email Share Back to top In a recent Brainwaves event hosted by the Society of Automotive Analysts and Foley & Lardner LLP, titled “100 Days and Beyond: Presidential Policy Shifts Impacting...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA — A Conversation with Richard E. Engler, Ph.D. and Kelly N....

This week, I discuss with my colleagues, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, and Kelly N. Garson, Senior Associate for B&C and Acta, our recently released...more

Blake, Cassels & Graydon LLP

Canada Publishes Final State of Per- and Polyfluoroalkyl Substances (PFAS) Report

Introduction - The Government of Canada has announced its intention to designate PFAS, a family of thousands of human-made chemicals known for their oil- and water-resistant properties, as “toxic” under the Canadian...more

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

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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

Bergeson & Campbell, P.C.

EPA Will Extend Deadline for Reporting Health and Safety Data for 16 Chemicals

The U.S. Environmental Protection Agency (EPA) announced on March 6, 2025, that it plans to issue a rule “soon” to extend the reporting deadline for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA)...more

Bergeson & Campbell, P.C.

EPA Reopens Comment Period on Proposed Risk Management Rule for PV29

On March 4, 2025, the U.S. Environmental Protection Agency (EPA) announced that it is reopening the comment period for the January 2025 proposed rule to address the unreasonable risk of injury to human health presented by...more

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