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CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Bergeson & Campbell, P.C.

Comments on Maine’s Proposed CUU Amendment Due September 2, 2025

The Maine Department of Environmental Protection (MDEP) began a public consultation on July 30, 2025, on a proposed amendment to Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

Ropes & Gray LLP on

The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

Beveridge & Diamond PC

Deadline Extended for Reporting PFAS in Products in Minnesota, Proposed Minnesota PFAS Reporting Rule under Administrative Review

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Under Minnesota’s PFAS in products law, manufacturers of products containing intentionally added per- and polyfluoroalkyl substances (PFAS) must report those products to the Minnesota Pollution Control Agency (MPCA) by...more

McDermott Will & Schulte

Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase out petroleum-based synthetic dyes from the US food supply by the end of 2026,...more

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Beveridge & Diamond PC

Coalition of US States and Cities Lays Groundwork for Legal Challenge of the Department of Energy’s Appliance Efficiency Rollback

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A multistate coalition of twelve state Attorneys General—California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Vermont, and Washington—joined by the District of...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Womble Bond Dickinson

An Increasing Regulatory Maze for Nontraditional Meat Products

Womble Bond Dickinson on

As this blog has previously covered, various states have passed laws prohibiting plant-based products from being labeled like traditional meat products. A recent Oklahoma law bans using terms like beef, chicken, or bacon to...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Bergeson & Campbell, P.C.

WDOE Proposes to Regulate PFAS in Certain Consumer Products

The Washington Department of Ecology (WDOE) issued a proposed rule on June 4, 2025, that would regulate per- and polyfluoroalkyl substances (PFAS) in certain consumer products. Beginning January 1, 2027, the proposed rule...more

Mitchell, Williams, Selig, Gates & Woodyard,...

2026 NPDES Multi-Sector General Permit for Stormwater Discharges: Steel Manufacturers Association Comments on Proposed Federal...

The Steel Manufacturers Association (“SMA”) submitted May 19th comments to the United States Environmental Protection Agency (“EPA”) addressing: Proposed 2026 Multi-Sector General Permit for Stormwater Discharges...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – June and July Filings

Carriers and providers of interstate and international telecommunications that seek to revise their May 1, 2025, Form 499-Q filing must do so within 45 days of the Form 499-Q filing deadline, i.e., by June 16, 2025 (because...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply: A Guide to New TSCA

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association’s Section of Environment, Energy, and Resources, titled...more

Bergeson & Campbell, P.C.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Troutman Pepper Locke

PFAS Regulatory Landscape Update — The Message? Stay Tuned.

Troutman Pepper Locke on

The Environmental Protection Agency (EPA) has announced several actions in recent weeks that shed light on the Trump administration’s approach to PFAS regulation....more

Akin Gump Strauss Hauer & Feld LLP

TSCA PFAS Reporting Deadline Extended

On May 12, 2025, the U.S. Environmental Protection Agency (EPA) issued an interim final rule to amend the reporting period under the per- and polyfluoroalkyl substances (PFAS) reporting rules issued in October 2023 under the...more

Beveridge & Diamond PC

PFAS Reporting Rule Deadlines Extended – and More Changes to Come

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The U.S. Environmental Protection Agency (EPA) published an interim final rule on May 13, 2025, extending the reporting deadlines for its Per- and polyfluoroalkyl substances (PFAS) Reporting Rule, 40 C.F.R. Part 705, which...more

Vorys, Sater, Seymour and Pease LLP

US EPA Delays TSCA PFAS Reporting and Hints at Revisions

US EPA again revised the reporting deadlines for manufacturers and importers of PFAS under the Toxic Substances Control Act (TSCA) Section 8(a)(7) rule. Like the prior extension, US EPA states that it needs additional time to...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Bergeson & Campbell, P.C.

Petitions Filed to Add Chemicals to List of Chemical Substances Subject to Superfund Excise Tax

On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances...more

Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

Burr & Forman on

After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

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