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
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)
On July 1, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 25-08, an unfavorable opinion discussing a proposed arrangement in which a medical device company...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more
On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more
On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more
Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more
In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
On February 19, 2021, the West Virginia Senate passed SB 277, the “COVID-19 Jobs Protection Act.” The purpose of the Act is stated to “eliminate the liability of the citizens of West Virginia and all persons including...more
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
In the last hours of its unusual 2020 legislative session, the Georgia General Assembly passed legislation providing COVID-19 liability protections for healthcare facilities, healthcare providers, property owners, sports...more
On June 4, 2020, the Kansas Legislature passed the COVID-19 Response and Reopening for Business Liability Protection Act. It now goes to Governor Laura Kelly for signature....more
Yesterday, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities. The order mandates that private, public, and quasi-public health care providers and...more
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more
Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more