In a move that will change how companies make decisions regarding sensitive technologies and products, President Trump signed into law the Maintaining American Superiority by Improving Export Control Transparency Act (the...more
On September 29, 2025, the United States significantly expanded the reach of export controls. The U.S. Department of Commerce's Bureau of Industry and Security ("BIS") released an interim final rule, that applies Entity List...more
10/3/2025
/ Bureau of Industry and Security (BIS) ,
Comment Period ,
Due Diligence ,
Entity List ,
Export Administration Regulations (EAR) ,
Export Controls ,
Foreign Entities ,
General Licenses ,
Military End Use ,
New Regulations ,
Trump Administration ,
U.S. Commerce Department
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry.
...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Judicial Review ,
Life Sciences ,
Mandamus Petitions ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Statutory Deadlines ,
Statutory Interpretation ,
Trump Administration
The pharmaceutical industry has benefitted from a generally duty-free import environment for decades, allowing pharmaceutical manufacturers and importers to develop extensive, multi-jurisdictional supply chains optimized for...more
9/30/2025
/ Customs and Border Protection ,
Duty Free ,
Healthcare ,
Imports ,
Life Sciences ,
Manufacturers ,
Patient Access ,
Pharmaceutical Industry ,
Regulatory Reform ,
Risk Management ,
Section 232 ,
Supply Chain ,
Supply Contracts ,
Tariffs ,
Trade Expansion Act of 1962 ,
Trump Administration ,
US Trade Policies
In June 2025, two former executives were each sentenced to more than three years in prison for conspiracy and failure to report hazardous products to the U.S. Consumer Product Safety Commission ("CPSC"), marking the first...more
7/15/2025
/ Consumer Product Safety Act (CPSA) ,
Consumer Product Safety Commission (CPSC) ,
Corporate Counsel ,
Corporate Executives ,
Criminal Prosecution ,
Enforcement Actions ,
Failure to Report ,
Goods or Services ,
Penalties ,
Product Defects ,
Regulatory Requirements ,
Regulatory Violations ,
Reporting Requirements ,
Risk Management
In this new trade landscape, it is more important than ever to coordinate customs and operational planning with income taxes and transfer pricing....more
5/22/2025
/ Customs ,
First Sale Doctrine ,
Foreign Policy ,
Foreign Relations ,
Goods or Services ,
Imports ,
Income Taxes ,
Inventory ,
Retail Market ,
Risk Management ,
Suppliers ,
Supply Chain ,
Tariffs ,
Tax Liability ,
Tax Planning ,
Transfer Pricing ,
Trump Administration
REGULATORY ISSUES & UPDATES -
Update on Australia's New Climate-Related Financial Disclosure Regime -
Australia's mandatory climate-related financial disclosure regime is inching closer to implementation after the proposed...more
9/23/2024
/ Clean Air Act ,
Clean Energy ,
Climate Change ,
Disclosure Requirements ,
Enforcement Actions ,
Environmental Policies ,
Environmental Protection Agency (EPA) ,
Environmental Social & Governance (ESG) ,
Greenhouse Gas Emissions ,
Greenwashing ,
Popular ,
Tax Credits
In City of Baltimore v. BP, et al., court holds that nuisance and tort claims are preempted by federal law and beyond the limits of state law....more
8/2/2024
/ BP PLC v Mayor and City Council of Baltimore ,
Clean Air Act ,
Climate Change ,
Fossil Fuel ,
Manufacturers ,
Natural Gas ,
Nuisance ,
Oil & Gas ,
Preemption ,
Statute of Limitations ,
Tort
The Department of Treasury, the Internal Revenue Service, and the Department of Energy finalized guidance on the requirements for new and used clean vehicles to be eligible for federal tax credits....more
5/15/2024
/ Automotive Industry ,
Clean Car Standards ,
Clean Energy ,
Department of Energy (DOE) ,
Due Diligence ,
Electric Vehicles ,
Federal Taxes ,
Foreign Entities ,
Inflation Reduction Act (IRA) ,
IRS ,
Proposed Guidance ,
Supply Chain ,
Tax Credits ,
U.S. Treasury
The Background: In August 2022, the United States Court of Appeals for the Second Circuit held in Murray v. UBS Securities, LLC., et al. ("Murray") that an employee suing his employer under the anti-retaliation provisions of...more
2/19/2024
/ Adverse Employment Action ,
Anti-Retaliation Provisions ,
Burden of Proof ,
Certiorari ,
Employees ,
Employer Liability Issues ,
Murray v UBS Securities LLC ,
Retaliation ,
Sarbanes-Oxley ,
SCOTUS ,
Whistleblower Protection Policies ,
Whistleblowers
New proposed Treasury and Department of Energy ("DOE") guidance, issued on December 1, 2023, offers clarity on which vehicles will be disqualified from the Clean Vehicle Tax Credit due to the inclusion of minerals or...more
1/3/2024
/ Automotive Industry ,
Clean Car Standards ,
Clean Energy ,
Department of Energy (DOE) ,
Electric Vehicles ,
Foreign Entities ,
Inflation Reduction Act (IRA) ,
IRS ,
Motor Vehicles ,
Proposed Guidance ,
Tax Credits ,
U.S. Treasury
On Friday, October 27, the Federal Trade Commission ("FTC") announced new amendments to the Safeguards Rule, requiring covered financial institutions to report certain data breaches to the FTC and reflecting its continuing...more
11/13/2023
/ Cybersecurity ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Financial Institutions ,
Financial Regulatory Reform ,
Financial Services Industry ,
FTC Act ,
Gramm-Leach-Blilely Act ,
New Amendments ,
Non-Bank Lenders ,
Personal Information ,
Popular ,
Privacy Rule ,
Risk Assessment ,
Risk Management ,
Safeguards Rule ,
Section 5
On March 23, 2023, the Federal Trade Commission ("FTC") announced that it would propose a "click to cancel" provision in its rules governing subscriptions and recurring memberships. According to the FTC, the proposed rule...more
On September 6, 2022, the U.S. Department of Commerce ("Commerce") released its implementation strategy for the Creating Helpful Incentives to Produce Semiconductors ("CHIPS") for America Fund, outlining how Commerce will...more
The Uyghur Forced Labor Prevention Act ("UFLPA" or the "Act") imposes new obligations on companies producing or sourcing goods from the Xinjiang Uyghur Autonomous Region of the People's Republic of China ("Xinjiang"). The key...more
7/14/2022
/ Biden Administration ,
China ,
Customs and Border Protection ,
Forced Labor ,
Goods or Services ,
Human Rights ,
Imports ,
Supply Chain ,
Trade Restrictions ,
US Trade Policies ,
Uyghur Forced Labor Prevention Act (UFLPA)
Court orders agency to provide better explanation for List 3 and List 4A by June 30, 2022.
On April 1, 2022, a three-judge panel of the U.S. Court of International Trade issued an opinion in a test case for more than...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
2/10/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Supply Chain
The Fifth Circuit's opinion creates a circuit split that raises the possibility of a Supreme Court review.
On December 13, 2021, the Fifth Circuit issued an en banc opinion in Cochran v. U.S. Securities & Exchange...more
The Federal Trade Commission ("FTC") recently issued an enforcement policy cautioning companies engaged in "negative option marketing" of potential legal action if the sign-up process for subscription services fails to...more
The Office of the United States Trade Representative ("USTR") is seeking comments on the possible reinstatement of Section 301 tariff exclusions on 549 Chinese-origin products. The Office of the United States Trade...more
10/29/2021
/ China ,
Comment Period ,
Exclusions ,
Imports ,
International Harmonization ,
Section 301 ,
Supply Chain ,
Tariffs ,
Trade Relations ,
US Trade Policies ,
USTR
In AMG Capital Management v. FTC, the U.S. Supreme Court ruled the Federal Trade Commission Act does not allow the FTC to seek, from violators of the Act, "equitable monetary relief" in the form of restitution or...more
9/23/2021
/ AMG Capital Management LLC v FTC ,
Department of Justice (DOJ) ,
Disgorgement ,
Enforcement Actions ,
Enforcement Authority ,
Equitable Relief ,
Federal Trade Commission (FTC) ,
FTC Act ,
FTCA Section 13(b) ,
Injunctive Relief ,
Permanent Injunctions ,
Restitution ,
SCOTUS
President Biden recently signed an Executive Order on Promoting Competition in the American Economy (the "Order") outlining 72 initiatives by more than a dozen federal agencies to combat "excessive" corporate consolidation...more
President Biden's Executive Order calls for an extensive reassessment and revamping of the federal government's cybersecurity defenses and incident response capabilities, establishing benchmarks that may inform standards...more
The Biden Administration's Executive Order directs the Department of Commerce and the Federal Trade Commission to establish pilot programs to develop product labels that inform consumers about the cybersecurity capacities of...more