Compliance Tip of the Day: M&A Domestic Issues
The Current State of the Holder Rule: Friend or Foe? — Moving the Metal: The Auto Finance Podcast
Non-Compete Compliance in 2025: State Trends and Employer Strategies
FTC and Florida Focus on Non-Competes, SCOTUS to Rule on Pension Withdrawal Liability - #WorkforceWednesday® - Employment Law This Week®
Podcast - Tips for Maintaining FTC Compliance When Using AI
From Banks to FinTech: The Evolution of Small Business Lending — The Consumer Finance Podcast
From Banks to FinTech: The Evolution of Small Business Lending — Payments Pros – The Payments Law Podcast
Driving Digital Security: The FTC's Safeguards Rule Explained — Moving the Metal: The Auto Finance Podcast
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — The Consumer Finance Podcast
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — Moving the Metal: The Auto Finance Podcast
Compliance Needs are Alive and Well: FTC's Recent Enforcement Activity
Podcast - New Guidance on Complying with FTC Rule on Deceptive and Unfair Fees
Podcast - Navigating the New Landscape of Private Equity in Healthcare
(Podcast) The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more
At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more
In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...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
Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more
Happy 2024! The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more
Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more
In March 2023, the Federal Trade Commission announced a number of consumer protection actions involving data privacy, COVID health claims, a robocall debt relief pitch scheme, and alleged harmful noncompete restrictions. The...more
Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more
In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
FTC’s New Health Products Guidance...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
LEGISLATION, REGULATIONS & STANDARDS - Evaluation of FDA Human Foods Program Finds Culture of “Constant Turmoil” - An independent review commissioned by the U.S. Food and Drug Administration (FDA) of the Human Foods Program...more