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Proposed Regulation Manufacturers

A&O Shearman

Sanctions and export controls expand further - Update

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In October, the U.S. Commerce Department unveiled new rules to tighten further a sweeping set of export controls first introduced a year previously, reducing the types of semiconductor manufacturing equipment and advanced...more

K&L Gates LLP

California's Updated Proposition 65 Regulations New Short-Form Warnings and More

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Longtime efforts by the California Office of Environmental Health Hazard Assessment (OEHHA) to amend the so-called “short-form” safe harbor warnings for California’s Proposition 65 appear to be nearing completion. On 13 June...more

Troutman Pepper

Treasury and IRS Issue Additional Domestic Content Guidance Under IRA and New Elective Safe Harbor

Troutman Pepper on

On May 16, the Treasury Department (Treasury) and the Internal Revenue Service (IRS) issued Notice 2024-41, which modifies Notice 2023-38 (Prior Guidance) by expanding the list of Applicable Projects (defined below) to...more

McDermott Will & Emery

Imported Drugs: (Possibly) Coming Soon to a State Near You

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

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Venable LLP

Preparing for the EU Cyber Resilience Act

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The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Wiley Rein LLP

[Webinar] PFAS Ban in Maine: What Companies Need to Know About the March 1 Deadline for Currently Unavoidable Use Requests -...

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Effective January 1, 2030, the sale of any industrial, commercial, or consumer product containing intentionally added Per- and Polyfluoroalkyl Substances (PFAS) will be banned in Maine unless the use of PFAS in the product is...more

BakerHostetler

Overview of the Proposed Regulations for Advanced Manufacturing Credits Under Section 45X

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As covered in our prior alerts, the Inflation Reduction Act enacted new renewable energy credits, including an advanced manufacturing production credit under Section 45X that provides tax credits to domestic producers and...more

Vinson & Elkins LLP

Treasury Issues Proposed Regulations on 45X Advanced Manufacturing Production Credit

Vinson & Elkins LLP on

On December 14, 2023, the Department of the Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) issued proposed regulations (the “Proposed Regulations”) providing additional guidance to taxpayers on the advanced...more

McDermott Will & Emery

Mobility@McDermott: Monthly Update (11/2023)

McDermott Will & Emery on

1. Proposal for EU directive for right to repair no longer covering motor vehicles - The European Parliament’s Internal Market and Consumer Protection Committee has voted on a draft report on the proposed EU directive...more

Holland & Knight LLP

Treasury Department, IRS Release Foreign Entity of Concern Proposed Regulations

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The U.S. Department of the Treasury and IRS on Dec. 1, 2023, released proposed rules under Section 30D of the Internal Revenue Code, the Clean Vehicle Tax Credit, as they relate to the definition of "foreign entity of...more

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

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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

Bradley Arant Boult Cummings LLP

California Takes the Wheel: A Closer Look at Privacy in Connected Vehicles

California, home to the highest number of registered vehicles in the U.S., is at the forefront of a critical issue – the privacy practices of automobile manufacturers and vehicle technology firms....more

Foley & Lardner LLP

Electrified Industrial Policy: IRS Proposed Regulations on Section 30D EV Tax Credits & EV Manufacturing Grants

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The Inflation Reduction Act of 2022 (the “IRA”) and the Infrastructure Investment and Jobs Act of 2021 (the “IIJA”) set in motion an ongoing series of changes that are aimed at transforming, among other things, the automotive...more

Sheppard Mullin Richter & Hampton LLP

The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants

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

Knobbe Martens

AI & the FDA

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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

Troutman Pepper

Updated IRS Guidance on Critical Minerals and Battery Components Has Demonstrable, Ongoing Implications for Domestic and Foreign...

Troutman Pepper on

Introduction - On March 31, the Internal Revenue Service (IRS) issued highly anticipated proposed regulations on electric vehicle (EV) tax credits. Driven by an ambitious climate agenda, the Biden administration has...more

Hogan Lovells

Federal Grants & Buy America: OMB Proposes Requirements for Federally Funded Infrastructure Projects

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In February, the Office of Management and Budget (OMB) proposed new Buy America regulations for Federal grants, to implement the Build America, Buy America (BABA) Act signed into law on November 15, 2021. BABA required that...more

Foley & Lardner LLP

Antitrust: Heightening Expansion, Review, and Enforcement

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Manufacturing companies should actively prepare for heightened antitrust scrutiny of their business practices in 2023, including practices that have not traditionally garnered the focus of the federal antitrust enforcers. ...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Holland & Knight LLP

Treasury Department Issues Section 48D Guidance on CHIPS Act Semiconductor Tax Incentive

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The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code to incentivize the manufacture of semiconductors and semiconductor manufacturing equipment in the United States. The credit is equal...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA

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

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

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

Sheppard Mullin Richter & Hampton LLP

Another Piece to the Puzzle: OMB Issues Proposed Guidance on “Build America, Buy America” Requirements

Coinciding nicely with the discussion of “Buy America” priorities at the February 7, 2023 State of the Union address, on February 9, 2023 the White House’s Office of Management and Budget (“OMB”) issued a proposed rule to...more

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