News & Analysis as of

Manufacturers Risk Mitigation

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

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

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device...

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Gabe Scannapieco, AGG Litigation & Dispute Resolution partner, to discuss enforcement trends affecting foreign...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Benesch

Trailer Manufacturing, Leasing, Interchange Liability

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The trucking industry recently received 450 million reasons to pay closer attention to best practices for trailer safety and the business relationships involving trailer use. On September 5, 2024, plaintiffs suing trailer...more

Ankura

7 Strategies to Overcome Supply Chain Disruptions: Mitigate Risk While Enhancing Resilience and Adaptability

Ankura on

Supply chain disruption and persistent inflation remain critical issues in the global economy, with ongoing geopolitical tensions, the evolution of digital threats, and increasing emphasis on sustainability reshaping the...more

ArentFox Schiff

As the (Customs and Trade) World Turns: September 2024

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Welcome to the September 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

K&L Gates LLP

PFAS and Other Emerging Alleged Contaminants Litigation: Mitigating Risk Through Insurance

K&L Gates LLP on

The United States (US) has seen an explosion of litigation in recent years relating to perfluoroalkyl and polyfluoroalkyl substances (PFAS), referred to by some as “forever chemicals” because they are slow to degrade and can...more

Goodwin

FTC Crackdown on False or Misleading “Made in the USA” Claims

Goodwin on

The US Federal Trade Commission (FTC) is intensifying a crackdown on goods that are falsely or misleadingly marketed as “made in the USA.” Since the FTC, in its Made in USA Labeling Rule, 86 FR 27022 (July 14, 2021), 16 C.F.R...more

Fisher Phillips

Snapshot on Manufacturing: Top 3 Compliance Challenges Stemming from OSHA and Labor Board Collaboration

Fisher Phillips on

Welcome to this edition of the FP Snapshot on Manufacturing, where we take a quick snapshot look at recent workplace law developments and examine how they impact employers in the manufacturing industry. In this edition, we’ll...more

K2 Integrity

[Webinar] Organized Retail Crime Roundtable: Minimizing Impact with Forward-Thinking Solutions - November 1st, 9:30 am PT

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Organized retail crime (ORC) is an all-too-common headline, with major retailers, distributors, manufacturers, and transportation providers across the United States being targeted. Retail crime not only has financial costs,...more

Womble Bond Dickinson

Supply chain disruption in Europe, UK and US: How businesses can mitigate risk

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After a long period of economic and political stability, the world entered an era of relative turmoil with the onset of the Covid-19 pandemic. The effects of this and subsequent events have been acutely felt by businesses....more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

Rumberger | Kirk

Rise In Lithium-Ion Battery Demand Causing Challenges

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The rising lithium-ion battery demand is creating challenges for manufacturers. It is important to understand how to mitigate risk. The rising demand to reduce our reliance on fossil fuels has driven product manufacturers to...more

Latham & Watkins LLP

5 Key Numbers: US Antitrust Insights for Manufacturers About Right-to-Repair Enforcement

Latham & Watkins LLP on

Private plaintiffs and government enforcers are aggressively attempting to revive antitrust theories challenging manufacturers’ policies that impact consumers’ “right to repair.” Manufacturers’ policies that impact how...more

Arnall Golden Gregory LLP

Honesty is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA

From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such...more

K&L Gates LLP

No Supplies in the Chain

K&L Gates LLP on

The world’s supply chains are crumbling. Manufacturing companies are struggling to catch up with surging demand as the global economy begins to recover from the pandemic-related impacts on production across all industries....more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

Wiley Rein LLP

U.S. Department of Energy Calls for Public Comment on High-Capacity Battery Supply Chain Vulnerabilities

Wiley Rein LLP on

On March 29, 2021, the Department of Energy (DoE) called for public comment on risks in the U.S. supply chain for high-capacity batteries, including electric vehicle batteries. DoE is seeking policy recommendations to address...more

Foley & Lardner LLP

Recent Impacts to the Automotive Supply Chain and Change Drivers for 2021

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The supply chain is the lifeblood of the automotive manufacturing industry. Disruptions to the supply chain caused by COVID-19 and component and material shortages, such as the semiconductor industry shortage, have put this...more

Foley & Lardner LLP

Wait, Why Am I Picking Up Your Tab? Iowa Considers Requiring Equipment Repurchases Where the Dealer Initiates Termination

Foley & Lardner LLP on

Equipment manufacturers are generally well aware of the onerous and often expensive equipment repurchase obligations they incur when terminating or non-renewing a dealer. But at least these repurchase obligations make some...more

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

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The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

American Conference Institute (ACI)

[Virtual Event] Advanced Legal, Regulatory and Compliance Forum on Over the Counter Drugs - February 26th, 9:00 am - 5:45 pm EST

A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more

BCLP

European Chemicals Agency SCIP Database is launched and ready for use

BCLP on

At the end of October, the European Chemicals Agency (ECHA) launched the SCIP database. When populated, the database will ensure that information on articles in the EU that contain substances of very high concern (SVHCs) is...more

American Conference Institute (ACI)

[Virtual Event] U.S. Export & Reexport Compliance For Canadian Operations - January 26th - 27th, 9:00 am - 5:00 pm EST

For a whole decade, ACI’s U.S. Export & Reexport Compliance for Canadian Operations conference continues to stand apart as the only practical, comprehensive event of its kind for the export compliance community in Canada. ...more

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