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
On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more
On July 30, 2025, the U.S. Environmental Protection Agency (EPA) issued a request for public comment on the potential regulation of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). PCE is a widely used...more
On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more
On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more
On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
The Maine Department of Environmental Protection (MDEP) began a public consultation on July 30, 2025, on a proposed amendment to Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The...more
California's Department of Toxic Substances Control (DTSC) has proposed listing microplastics on its "Candidate Chemicals List" under the Safer Consumer Products (SCP) Program, a regulatory framework designed to reduce toxic...more
On July 14, 2025, the Commerce Department announced new investigations initiated by the Secretary of Commerce on July 1, 2025, pursuant to Section 232 of the Trade Expansion Act of 1962. The pre-publication Federal Register...more
The California Department of Toxic Substances Control (DTSC) has taken a step toward regulating microplastics. On June 20, 2025, DTSC proposed to add microplastics to its Candidate Chemical List (CCL) under the state’s Safer...more
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more
Minnesota’s Pollution Control Agency (MPCA) held a public hearing on May 22, 2025 concerning its proposed rules that would implement PFAS-in-products reporting requirements and associated fees on entities covered by Amara’s...more
The Federal Communications Commission’s (FCC or Commission) Public Safety and Homeland Security Bureau (Bureau) and Office of Engineering and Technology (OET) have published a Public Notice seeking input on adding certain...more
On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
The U.S. Environmental Protection Agency announced on May 12, 2025, an interim final rule that would extend the dates of the reporting period for data submitted on the manufacture of perfluoroalkyl or polyfluoroalkyl...more
On April 21, 2025, the Minnesota Pollution Control Agency (MPCA) issued the proposed PFAS in Products: Reporting and Fees Rule for public consultation. The proposed rule details how the MPCA will require manufacturers to...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
On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances...more
After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules. The proposed regulations, which ADEM released for public notice and...more
Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more
On November 20, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension to the comment period for the notice published September 30, 2024, seeking public comment on the manufacture of certain per- and...more