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
For years, the U.S. International Trade Commission maintained that the potent remedies available under Section 337 were unavailable to intellectual property owners considered to be nothing more than “mere importers.” That...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
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
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
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
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
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
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
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more
Two recent court decisions examined the reach of U.S. antitrust laws to protect against injuries affecting global supply chains. The Foreign Trade Antitrust Improvement Act (FTAIA) limits the application of U.S. antitrust...more