News & Analysis as of

Manufacturers Risk Mitigation

ArentFox Schiff

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

ArentFox Schiff on

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

K2 Integrity on

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

Womble Bond Dickinson on

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

Rumberger | Kirk on

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

Foley & Lardner LLP on

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

Hogan Lovells on

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

Environmental General Counsel PC

Getting Tough on Vapor Intrusion: Enforcement for Failure to Mitigate

As concerns have escalated about vapor intrusion, regulatory agencies are not only taking more conservative approaches to risk – they may also be more likely to take enforcement action where there is delay or non-compliance...more

Kidon IP

Outsourced Manufacturing and Trade Secrets: Manufacturing Process & Personnel (Part 7)

Kidon IP on

After deciding on the basic corporate or contractual structure, the company should decide how best to strategically divide the manufacturing process. In the outsourced manufacturing context, the best process involves not only...more

Kidon IP

Outsourced Manufacturing and Trade Secrets: Internal Controls (Part 4)

Kidon IP on

When a company, for the soundest of business reasons, is exploring placing its crown jewels, its intellectual assets, in the hands of a third party, proper internal controls are vital. A company’s internal controls may...more

Foley & Lardner LLP

Accelerating Trends: Assessing the Supply Chain in a Post-Pandemic World

Foley & Lardner LLP on

This report identifies resiliency and innovation considerations for manufacturers and provides frameworks and tools for you to evaluate how those considerations impact your business....more

Alston & Bird

FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

Alston & Bird on

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more

61 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide