Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
Long-Term Part-Time Employee Eligibility Rules Now in Effect — Troutman Pepper Podcast
Exámenes de constitucionalidad a la reforma tributaria ¿en qué vamos?
Excitement, Turbulence & Confusion: The Top 10 Employment Law Issues That Affected Federal Contractors in 2023
The New Proposed Regulations on DAFs: Taxable Distributions and the Penalty Tax
New Proposed Regulations Defining Donor Advised Fund Terms
An Introduction to DAFs and Overview of the Newly Proposed DAF Regulations
Podcast: What Employers Should Know about the Pregnant Workers Fairness Act [More with McGlinchey, Ep. 62]
The Standard Formula Podcast | Bermuda Monetary Authority Proposes Enhancements to its Regulatory Regime
Monthly Minute | Current and Proposed Crypto Regulation
#WorkforceWednesday: AI Technology Regulations, Transparency in AI, OSHA's Permanent COVID-19 Standard - Employment Law This Week®
Overview of California’s New Proposed Cannabis Regulations
Proposed EU Regulation on AI - Impact and Ripple Effect
More CBD Certainty: Clearing Confusion over Hemp in New York State
JONES DAY TALKS®: Proposed Regs Implement FIRRMA, Expand CFIUS’s Jurisdiction Over Foreign Investments
Podcast: Health Reimbursement Arrangements
Qualified Opportunity Zone Fund Investments
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more
On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
The New York State Department of Financial Services has issued draft proposed comprehensive regulations of Pharmacy Benefit Managers (PBMs) in an attempt to eliminate anti-competitive activity and control prescription drug...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
During the October 11, 2023, Massachusetts Public Health Council Meeting, staff representing the Department of Public Health’s Drug Control Program introduced proposed revisions to 105 CMR 700.000: Implementation of M.G.L....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more
Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more
The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...more
Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more
The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more
Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more
Report on Supply Chain Compliance 3, no. 5 (March 5, 2020) - Republican Sen. Josh Hawley of Missouri announced via Twitter that he would introduce legislation to protect the U.S. medical product supply chain following its...more