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Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

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The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

Bergeson & Campbell, P.C.

TSCA Section 21 Petition Seeks Reconsideration of 2024 Rule Regarding Procedures for Chemical Risk Evaluation

On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

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What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Bergeson & Campbell, P.C.

Setting the Record Straight: New Chemical Review Needs Scientists

On May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

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Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

Bergeson & Campbell, P.C.

EPA Releases Final Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination for 1,4-Dioxane

On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances...more

Holland & Knight LLP

EPA Issues a Final Revised Risk Determination for 1,4-Dioxane

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The U.S. Environmental Protection Agency (EPA) concluded its risk evaluation of 1,4-Dioxane under the Toxic Substances Control Act (TSCA) and issued a Notice of Availability of its Final Supplement to the Risk Evaluation and...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?

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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

Downey Brand LLP

EPA Adds Extensive New Amendments to its Risk Management Program in Final Rule

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On March 11, 2014, the Environmental Protection Agency (EPA) published in the Federal Register amendments to the Risk Management Program (RMP) rule (Final Rule). Going into effect on May 10, 2024, EPA’s Final Rule, named the...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

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Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Foley Hoag LLP - Global Business and Human...

A Human Rights Impact Assessment of Microsoft's Enterprise Cloud and AI Technologies Licensed to U.S. Law Enforcement Agencies

Microsoft is one of the world’s leading technology companies. Its products and technologies are in offices, classrooms, and homes. Additionally, governments use them to help conduct vital public services. Microsoft is also...more

Beveridge & Diamond PC

TSCA Sticker Shock: EPA Proposes Large Fee Increases

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Does your company manufacture domestically or import chemicals that the U.S. Environmental Protection Agency (EPA) is reviewing under section 6 of the Toxic Substances Control Act (TSCA)? Does your company submit applications...more

Beveridge & Diamond PC

China Sets out a Regulatory Roadmap to Control New Chemicals

On May 24, 2022, China State Council issued an Action Plan on New Pollutants Governance (“Plan”) to set out a regulatory roadmap to control new chemicals and outline an enhanced enforcement framework for compliance. The Plan...more

Tucker Arensberg, P.C.

Biden Warns of Imminent Cyberattacks and New Regulations– Is Your Business Prepared?

Tucker Arensberg, P.C. on

Our clients in financial services, technology, and manufacturing industries, take note of this important new piece of legislation. On March 21, 2022, President Biden warned American businesses to prepare for imminent...more

Robinson+Cole Manufacturing Law Blog

Chemical “Risk Management Rules” on the Horizon for 2021

The Toxic Substances Control Act (TSCA) has long provided EPA with authority to review new chemical substances in a gatekeeper role as such substances enter U.S. commerce. ...more

Bergeson & Campbell, P.C.

EPA Releases Final Chemical Risk Evaluation for NMP

On December 23, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for N-methylpyrrolidone (NMP). Of the 37 conditions of use that EPA reviewed, EPA found that 26 present unreasonable...more

Bergeson & Campbell, P.C.

EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses

On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and...more

Robinson+Cole Manufacturing Law Blog

TSCA Implementation Update: EPA Releases Updated Inventory and Delays Risk Evaluations

As we previously outlined, the Toxic Substances Control Act (“TSCA”) was amended in 2016 to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in commerce)....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, February 2018

TSCA/FIFRA/TRI - Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the...more

Jones Day

An Assessment and Comparison of New TSCA and REACH

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Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or "New Toxic Substances Control Act," introduces a number of changes to regulations for the collection and assessment of information concerning...more

Robinson+Cole Manufacturing Law Blog

TSCA Implementation Update: EPA Finalizes Framework Rules and Announces Scope For First Risk Evaluations

TSCA Framework Rules Promulgated - As we outlined last year, the Toxic Substances Control Act (“TSCA”) was recently updated to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those...more

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