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Wiley Rein LLP

FDA Withdraws “Standardized” Asbestos Testing Proposal for Talc-Containing Cosmetics, With Intent to Reexamine and Reissue

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On November 28, 2025, the U.S. Food and Drug Administration (FDA) withdrew its 2024 proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.” 90 FR 54603. The...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

In October 2025, the FDA released a revised guidance titled, “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers.” The document updates prior interpretations of 21 C.F.R. Part 312, Subpart I,...more

Foley Hoag LLP - State AG Insights

SCOTUS Considers Pre-Enforcement Challenges to State AG Subpoena: Oral Arguments in First Choice Women's Resource Centers, Inc. v....

Key Takeaways: The Supreme Court heard oral arguments in First Choice Women’s Resource Centers v. Platkin, Docket No. 24-781, on December 2, 2025, concerning the administrative subpoena sent by the New Jersey Attorney...more

Nelson Mullins Riley & Scarborough LLP

2026 Cost-of-Living Adjustments for Benefit Plans

The IRS has released the 2026 cost-of-living adjustments to certain limits, thresholds and penalties that apply to employee benefits plans and programs. The following charts provide the applicable limits for 2026 in...more

Morgan Lewis - As Prescribed

Impacts of FDAs Slimming of Biosimilar Requirements

FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposes...more

Morgan Lewis

UK-US Pharmaceutical Trade Deal: Impact on UK Drug Pricing, Tariffs, and Investment

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A landmark agreement between the UK government and the US administration guarantees zero tariffs on UK pharmaceutical exports to the United States for at least three years in exchange for commitments from the United Kingdom...more

Hogan Lovells

DOJ Subpoenas, Scientific Exchange, and Deference to Doctors – What We Are Watching

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The U.S. Department of Justice's recent subpoenas and the Hsiao Declaration signal a potential redefinition of enforcement boundaries under the Food, Drug, and Cosmetic Act (FDCA). By asserting that off-label prescribing may...more

Holland & Knight LLP

2026 Legislative and Regulatory Outlook

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As the new legislative year approaches, organizations and stakeholders face a rapidly evolving policy landscape shaped by congressional priorities and executive branch initiatives. It's important to note that the U.S....more

Holland & Knight LLP

CMMI Launches Voluntary Payment Model for Qualifying Chronic Conditions with Tech-Enabled Care

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The Centers for Medicare & Medicaid Services (CMS) has announced that the Center for Medicare and Medicaid Innovation (CMMI) is testing an outcome-aligned payment (OAP) approach designed to give Medicare fee-for-service (FFS)...more

Rivkin Radler LLP

Elder Law Is for Everyone Part 2: Medicaid Homecare

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Often, people with long-term medical or cognitive conditions that limit their ability to manage their daily care need in-home assistance. Since home care typically costs between $25 and $35 an hour, without long-term care...more

Akin Gump Strauss Hauer & Feld LLP

Fostering the Future for American Children and Families (Trump EO Tracker)

Directs the Department of Health and Human Services (HHS) to modernize the nation's child-welfare system by improving data collection, updating state systems, expanding the use of advanced technology, and publishing annual...more

McDermott+

Rural Health Transformation Program: What you need to know

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The Rural Health Transformation (RHT) Program is a five-year, $50 billion initiative established under the One Big Beautiful Bill Act to strengthen healthcare delivery in rural communities....more

Cozen O'Connor

Bipartisan AGs Urge Shopify to Filter Out E-Cigarette Sellers from Its Platform

Cozen O'Connor on

California AG Rob Bonta and the City of New York were joined by a bipartisan coalition of 24 AGs in sending a letter to Shopify Inc., urging the company to crack down on merchants using its e-commerce platform to sell illegal...more

Sheppard Mullin Richter & Hampton LLP

California Issues Two-Year Freeze on PACE Applications: What Providers Need to Know

The California Department of Health Care Services (“DHCS”) announced via a Policy Letter that the state has paused the application process for Program of All-Inclusive Care for the Elderly (“PACE”) organizations for a minimum...more

Seyfarth Shaw LLP

The Week in Weed: December 2025

Seyfarth Shaw LLP on

Welcome back to the Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, the big news is out of Virginia, where there’s some progress on a retail market bill. Medicare may begin...more

Troutman Pepper Locke

Blue-State AGs Tap Rohit Chopra to Lead Consumer Protection Working Group

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As reported by Bloomberg, the Democratic Attorneys General Association (DAGA) has hired Rohit Chopra, former Director of the Consumer Financial Protection Bureau (CFPB or Bureau), to lead a new Consumer Protection and...more

King & Spalding

CMS Issues Preliminary Guidance on Provider Taxes Under Sections 71115 and 71117 of the Working Families Tax Cuts Act

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On November 14, 2025, CMS issued a press release and accompanying letter providing preliminary guidance to states on the implementation of new federal requirements governing health-care-related (i.e., provider) taxes under...more

Troutman Pepper Locke

12 Days of Regulatory Insights: Day 2 – How AGs Are Shaping Health Care Markets — Regulatory Oversight Podcast

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In this episode of our special 12 Days of Regulatory Insights podcast series, Chris Carlson, a partner in our RISE practice group and member of the State Attorney General (AG) team, is joined by colleagues Lauren Fincher,...more

Winthrop & Weinstine, P.A.

Minnesota To Issue Licensing Moratorium on Home and Community Based Services

The Minnesota Department of Human Services (“DHS”) quietly communicated on December 1, 2025, its intent to issue a temporary licensing moratorium for 245D-licensed Home and Community Based Services (“HCBS”), effective January...more

Hogan Lovells

When Culture Outpaces Compliance: A Wake-Up Call for US Medical Device Manufacturers

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In the labyrinthine world of medical device manufacturing, process is king—but culture wears the crown. Peter Drucker's adage, “Culture eats strategy for breakfast,” has long echoed through boardrooms, but within regulated...more

Foley Hoag LLP

CMS Announces ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model

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Key Takeaways: The ACCESS Model1 tests an outcome-aligned payment (OAP) approach designed to give people with Original Medicare new options to improve their health and prevent and manage chronic disease with...more

Hogan Lovells

Milestone US-UK Drug Tariff and Pricing Deal Announced

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The U.S. and UK have announced a pharmaceutical tariff and pricing deal in which the UK government agreed to increase investment in innovative medicines, and U.S. President Trump agreed to exempt the UK from certain...more

Phelps Dunbar

Heads Up for Health Care Professionals: AI Tools Could Be a Legal Minefield

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AI is changing the game in patient care. From wearable sensors that track vitals to predictive alerts that flag early signs of deterioration, these tools are helping clinicians intervene faster and smarter. But here’s the...more

Dentons

Ep. 89 – Three Red Flags to Watch for to Lower Your False Claims Act Risk

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In a recently settled False Claims Act case, the Department of Justice (DOJ) highlighted several alleged practices that offer important lessons for compliance professionals. While the case settled with no admission of...more

Haynes Boone

MoCRA Update: FDA Withdraws Proposed Talc Rule, Citing MAHA Priorities and Testing Complexities

Haynes Boone on

On November 28, 2025, while most cosmetic companies were promoting their “Black Friday” deals for this year, the FDA quietly issued a Federal Register notice withdrawing the Agency’s previously proposed regulation for...more

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