Build America Buy America What is it? How to qualify.
Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Powering Through the Environmental Challenges of EV Development - Energy Law Insights
Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
Perfecting High-Performance Battery Chemistry With John Kem, American Battery Factory — Battery + Storage Podcast
Hot Topics in international trade
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
Hot Topics in International Trade A Year in Review (Quickly)
Domesticating the Battery Supply Chain With ENTEK and KORE Power — Battery + Storage Podcast
What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
Podcast - Made in the USA Claims
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more
Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more
On Friday, July 9, 2021, President Biden issued a sweeping Executive Order that could have far-reaching implications for businesses across a broad spectrum of industries. The Executive Order takes a government-wide approach...more
Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more
Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.” Industry experts...more
On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more
The Department of Justice (DOJ) Antitrust Division announced three new investigations and several developments in its other investigations, including new investigations in the commercial flooring industry, online auctions for...more
Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more
I undertook a presentation on April 17th at the Arkansas Environmental Federation Regulated Waste Seminar titled: Solid and Hazardous Waste Judicial/Regulatory Developments: 2018 – 2019 - The discussion addressed...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more
ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more