News & Analysis as of

Foreign Manufacturers

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[Webinar] What is the ITC and How to Minimize Your Risk of Being Sued in that Forum - July 19th, 1:00 pm - 2:00 pm EDT

Danny Yonan, Director and head of the firm’s ITC practice, and Directors Uma Everett and Paul Ainsworth will present the webinar "What is the ITC and How to Minimize Your Risk of Being Sued in that Forum" on Wednesday, July...more

Barnea Jaffa Lande & Co.

Drastic Measures to Reduce Concentration and Increase Competition in the Israeli Food and Toiletries Market

The Israeli Ministry of Finance and the Competition Authority published a public appeal to submit positions with regard to their plan to reduce concentration and increase competition in the food and toiletries market, which...more

Jackson Lewis P.C.

Independent Unions Continue Gains at U.S. Manufacturers in Mexico Under Mexican Labor Law Reform

Jackson Lewis P.C. on

The United States imported more than $385 billion worth of goods from Mexico in 2021. Mexico is America’s second largest trading partner, and many U.S. manufacturing companies, including the automotive and aerospace...more

Faegre Drinker Biddle & Reath LLP

Foreign Manufacturer Dismissed for Lack of Personal Jurisdiction in the Southern District of Indiana

Case: Patterson v. Chiappa Firearms, USA, LTD, No. 1:20-cv-01430-JPH-MG, 2021 WL 4287431 (S.D. Ind. Sept. 21, 2021). Significance: - First Indiana case to apply the “relate to” standard articulated in Ford Motor Co....more

Epstein Becker & Green

Key Considerations for Reshoring U.S. Drug Manufacturing

Epstein Becker & Green on

This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more

Sheppard Mullin Richter & Hampton LLP

Nota Bene Episode 100: The New World Trade Order with Scott Maberry

We are celebrating our 100th episode of the Nota Bene podcast by welcoming back our very first guest on the show, Scott Maberry, to examine the shifts over the past three years away from the world economic order that has...more

Troutman Pepper

Sanitizing Hand Sanitizer — Managing FDA-Recalled Hand Sanitizer

Troutman Pepper on

In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and...more

Pillsbury - Global Trade & Sanctions Law

U.S. Commerce Department Imposes New Restrictions on Huawei

On August 17, 2020, the U.S. Department of Commerce Bureau of Industry and Security (BIS) made available for public inspection a final rule expanding restrictions on Huawei Technologies Co., Ltd. and its non-U.S. affiliates...more

McGlinchey Stafford

Personal Jurisdiction: Not what you learned in law school [More with McGlinchey Ep. 4]

McGlinchey Stafford on

How is it that in 2020, we are still discussing personal jurisdiction? Wasn’t this decided in the last century? What has changed? These questions have become increasingly relevant following sea change decisions in Goodyear,...more

Society of Corporate Compliance and Ethics...

Chinese manufacturer receives approval to deliver N95 masks to California

Report on Supply Chain Compliance 3, no. 13 (June 25, 2020): Chinese auto manufacturer BYD Auto Co. Ltd. received approval from the United States National Institute for Occupational Safety and Health (NIOSH) to sell U.S....more

Bergeson & Campbell, P.C.

Senate Finance Committee Holds Hearing on FDA’s Foreign Drug Manufacturing Inspection Process

On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and...more

Hogan Lovells

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

Hogan Lovells on

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more

Butler Snow LLP

You Can’t Say – “Made in China”

Butler Snow LLP on

In today’s global economy, product liability defense counsel must consider the location a product was manufactured and be prepared to defend —including by seeking the exclusion of—decisions to manufacture abroad. These...more

Hogan Lovells

Lessons Learned from Post-9/11 and Anthrax Experiences to be Applied to Covid-19 in the Food Industry

Hogan Lovells on

As we face huge challenges from COVID-19, I am reminded daily of the parallels we faced in the 9/11 aftermath and related Anthrax incident nearly 20 years ago when I was Director of FDA’s Center for Food Safety and Applied...more

BakerHostetler

FDA Current Good Manufacturing Practice Inspections During the COVID-19 Pandemic

BakerHostetler on

In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more

Sheppard Mullin Richter & Hampton LLP

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract...more

Bilzin Sumberg

A Recipe for Disaster: The Impact of COVID-19 on Food Safety and the Food Industry

Bilzin Sumberg on

The rapid spread of COVID-19 (also commonly referred to as “novel coronavirus”) has caused nations and organizations across the world to take emergency action in the interest of public health. Most companies are issuing...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Warning Letter for Refusal to Permit Inspection: Important Takeaways for Startups and Drug and Device Manufacturers

Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more

Maynard Nexsen

Foreign Manufacturer + Union Campaign = Netflix Documentary... and Some Valuable Lessons for Employers

Maynard Nexsen on

A few years ago, a major Chinese manufacturer, Fuyao, opened the world’s largest windshield-making plant in Ohio. Fuyao renovated an old General Motors facility, invested millions in state-of-the-art machinery and hired...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Mintz - Health Care Viewpoints

In Policy Reversal, HHS and FDA Propose Plan to Import Foreign Drugs

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019

Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more

Robinson+Cole Manufacturing Law Blog

Advice for Foreign Manufacturers Looking To Grow In The United States

Over the past few months I have had the pleasure to participate in several significant manufacturing events, including events at The White House, the Department of Commerce, and most recently, at the first International Space...more

Patrick Malone & Associates P.C. | DC Injury...

Generic drugs ensnared in price-fixing and shoddy manufacturing claims

With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more

WilmerHale

WTO Panel Issues Mixed Decision in Softwood Lumber Dispute; Upholds US “Zeroing” Methodology

WilmerHale on

On April 9, 2019, a World Trade Organization (WTO) dispute settlement panel issued its ruling in the most recent installment of the long-running US–Canada softwood lumber dispute. The panel’s decision is notable for its...more

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