On Demand, On Purpose: Fashion Manufacturing That Doesn’t Cost the Earth
Podcast - Diamond Alternative Energy, LLC v. EPA: The Intersection of Constitutional and Environmental Law
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
Wiley's 2025 Key Trade Developments Series: Trade Remedies
Wiley's 2025 Key Trade Developments Series: U.S.-Mexico-Canada Agreement (USMCA)
Business Better Podcast Episode - Manufacturing Moment: How State Associations Navigate the Policy Landscape
Business Better Podcast: Manufacturing Moment - Manufacturers’ Priorities for the New Administration
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
12 Days of Regulatory Insights: Day 9 - Trends in the Tobacco Industry — Regulatory Oversight Podcast
5 Key Takeaways | State Sales Tax in 2024: What Every Retailer Needs to Know
Hot Topics in International Trade - 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)
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more
Packaging-related EPR laws are rapidly creating complex compliance obligations across multiple states; companies should act to avoid unexpected fees, increased costs and competitive disadvantages....more
Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more
Producers of packaging and other covered products are facing near-term deadlines to pay fees or register for programs intended to subsidize recycling in many states. With an initial fee payment due on July 1, 2025, for more...more
Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The...more
On May 14, Alabama Gov. Kay Ivey signed Alabama HB8 into law. Effective June 1, HB8 introduced sweeping changes that will reshape how nicotine products are sold, marketed, and regulated in Alabama. You heard that right,...more
A lot is going on in the extended producer responsibility (“EPR”) packaging world this month. Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws. And this week, just a...more
This week Maryland’s Governor Wes Moore signed Senate Bill 901, an Extended Producer Responsibility (EPR) law designed to make “producers” of packaged items and paper products financially responsible for the upgrades to state...more
With the January 1, 2026, reporting deadline fast approaching for reporting on products containing intentionally added per- and polyfluoroalkyl substances (PFAS), on April 21, 2025, the Minnesota Pollution Control Agency...more
Companies that manufacture any of five chemicals are facing substantial fee payments under the Toxic Substances Control Act. The U.S. Environmental Protection Agency (EPA) has published preliminary lists of manufacturers that...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...more
On Wednesday, October 23, 2024, FCA US LLC, the manufacturer of Chrysler, Jeep, Dodge, Ram vehicles, among others, put the final nail in the coffin of claims by consumers that “destination charges” for the delivery of...more
As global manufacturers pivot away from China and set their sights on Vietnam, the country’s labor and employment landscape is rapidly changing. This surge in demand from Europe and the U.S. has not only sparked economic...more
On March 31, Circular Action Alliance (“CAA”), the Producer Responsibility Organization (“PRO”) for California, Colorado, and the only contender for PRO in Oregon, submitted the first draft of its Program Plan (“the Plan”)...more
Does your company manufacture domestically or import chemicals that the U.S. Environmental Protection Agency (EPA) is reviewing under section 6 of the Toxic Substances Control Act (TSCA)? Does your company submit applications...more
Amid historic and massive increases in inflation[1] and unprecedented supply chain challenges, the Environmental Protection Agency (EPA or Agency) raised its Toxic Substances and Control Act (TSCA) fees by 18.9%. These fees...more
As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more
On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more
On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help...more
On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule. Specifically, the proposed updates to the...more
On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more