Daily Compliance News: July 21, 2025, The More Reasons Not to Go to China Edition
Daily Compliance News: July 7, 2025 the Disaster on the River Edition
Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
State AG Pulse | The Inside Scoop: On Being Chief Deputy
Consumer Finance Monitor Podcast Episode: Challenges of Using the Current Law to Address Dark Patterns, with Guest Gregory Dickinson, Assistant Professor, St. Thomas University
Consumer Finance Monitor Podcast Episode: Should Written Contracts be Eliminated for Small Dollar Transactions? With David Hoffman, University of Pennsylvania Carey Law School
Troutman Pepper Attorneys Update Fair Lending Handbook for the American Association of Bank Directors - The Consumer Finance Podcast
Season 2 Episode 4 - Russia Enforcement and the involvement of DOJ's Task Force KleptoCapture
PLI's inSecurities Podcast: A View From the Inside
Consumer Finance Podcast Monitor Episode: The Consumer Financial Protection Bureau’s Final Section 1071 Rule on Small Business Data Collection: What You Need to Know, Part II, Guest David Skanderson
Podcast Episode 179: How to Start and Succeed at Creating Your Law Firm Podcast
Winstead HOA Law Webinar: Deed Restriction Compliance – Legal Process
The Labor Law Insider - Pause Before You Discipline: NLRB Turns Against Civility in Lion Elastomers Decision
A Glimpse Into the Other Side: Understanding the Perspective of Government Enforcers
The Justice Insiders Podcast: The Latest on Russia Sanctions and the Enhanced Enforcement Environment
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 142: Erica Barnes, Maynard Nexsen Attorney
PLI's inSecurities Podcast: Whistling the Same Tune: Building an Effective Whistleblower Program
Time to Amend the Defend Trade Secrets Act
PODCAST: Williams Mullen's Trending Now - An IP Podcast: NIL - Trending Issues Related to the NCAA’s Name, Image and Likeness Policy in 2023
PLI's inSecurities Podcast - Compliance and Enforcement Considerations for Private Funds & RIAs
A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more
Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
The U.S. Court of Appeals for the First Circuit recently upheld multiple misdemeanor convictions for two former medical device company executives under the Food, Drug and Cosmetic Act (FDCA). While the former executives...more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance)....more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more
The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more