Key Considerations for Reshoring U.S. Drug Manufacturing
Nota Bene Episode 100: The New World Trade Order with Scott Maberry
Personal Jurisdiction: Not what you learned in law school [More with McGlinchey Ep. 4]
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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