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Bricker Graydon LLP

Key Provisions and Implications of House Bill 331

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On December 18, 2024, the Ohio General Assembly passed House Bill 331 which created a new process for dissolution of villages in Ohio. This new process is in addition to the existing procedure for the dissolution of a village...more

Hogan Lovells

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

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On January 14, 2025, the U.S. Food and Drug Administration (FDA) issued its proposed rule on front-of-package nutrition labeling (FOPNL). With certain exemptions, the proposed rule would require food products to display an...more

Hogan Lovells

FDA unveils long-awaited guidance on AI use to support drug and biologic development

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The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

DLA Piper

CBP Proposes Rule that Would Eliminate Section 321 De Minimis Exemption Eligibility for Shipments Subject to Section 301 Tariffs

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In the final days of the Biden administration, US Customs and Border Protection (CBP) issued several notices of proposed rulemaking (NPRM) aimed at restricting use of the “de minimis” imports provisions of Section 321(a)(2)...more

Troutman Pepper Locke

CFPB Highlights Fair Lending Risks in Advanced Credit Scoring Models

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Last week, the Consumer Financial Protection Bureau (CFPB or Bureau) released its latest Supervisory Highlights report, focusing on the use of advanced technologies in credit scoring models. ...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

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In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

Cozen O'Connor

Ice Raids and I-9 Audits: What You Need To Know If They Come Knocking

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As noted by multiple media outlets, Donald Trump’s team released an aggressive slate of immigration executive orders. This anticipated immigration crackdown will have implications for people nationwide, including a package of...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

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In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

Foley & Lardner LLP

2023 AI Executive Order Revoked

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On January 20, 2025, President Donald Trump signed an executive order rescinding the 2023 directive issued by former President Joe Biden on artificial intelligence (AI). Biden’s order outlined extensive measures aimed at...more

Troutman Pepper Locke

Behind the Scenes: The Role of Senior Staff in AG Offices — Regulatory Oversight Podcast

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In this episode of Regulatory Oversight, Chuck Slemp welcomes Lacey Mase, the chief deputy attorney general (AG) of Tennessee, to explore the inner workings of an AG's office and the pivotal role of its senior staff in...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Harris Beach Murtha PLLC

Trump 2.0 Executive Action on Immigration – Reading Between the Lines

On January 20, 2025, President Donald Trump signed a series of executive orders significantly altering U.S. immigration policy. These actions, aimed at strengthening border security and redefining citizenship criteria, have...more

Foley & Lardner LLP

DEA Unveils Long-Overdue Special Registration for Telemedicine in Proposed Rule

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In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more

King & Spalding

OIG Audit Finds That Medicare Could Achieve Significant Savings if Critical Access Hospital Payments for Swing-Bed Services Were...

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On January 3, 2025, OIG posted the results of an audit that found that Medicare could have saved $7.7 billion if critical access hospitals’ (CAH) payments for swing-bed services were similar to those of the fee-for-service...more

Allen Matkins

Has California Imposed Nationwide Price Controls?

Allen Matkins on

On January 7, 2025, Governor Newsom proclaimed a State of Emergency in Los Angeles and Ventura Counties due to the fire in the Pacific Palisades and windstorm.  This proclamation triggered price the application of California...more

Troutman Pepper Locke

Behind the Scenes: The Role of Senior Staff in AG Offices — Regulatory Oversight Podcast

Troutman Pepper Locke on

In this episode of Regulatory Oversight, Chuck Slemp welcomes Lacey Mase, the chief deputy attorney general (AG) of Tennessee, to explore the inner workings of an AG's office and the pivotal role of its senior staff in...more

Foley & Lardner LLP

President Trump’s Inauguration Day Immigration Executive Orders

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During President Trump’s first hours in the White House, he issued a sweeping series of executive orders, including several regarding immigration policy: Protecting the American People Against Invasion, Securing Our Borders,...more

Robinson & Cole LLP

Legal Update: Nasdaq Board Diversity Rules Struck Down in Court

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On December 11, 2024, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Alliance for Fair Board Recruitment v. SEC, held that the approval by the U.S. Securities and Exchange Commission (SEC) of the Nasdaq...more

Polsinelli

CBP’s Proposed Changes to De Minimis Shipments

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This week, U.S. Customs and Border Protection (CBP) published two Notices of Proposed Rulemaking that could significantly impact and curtail the entry of low-value shipments not exceeding $800 (commonly known as de...more

Troutman Pepper Locke

NCUA Releases its 2025 Supervisory Priorities

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On January 7, the National Credit Union Administration (NCUA) released its supervisory priorities for 2025, outlining the key areas of focus for federally insured credit unions. This guidance is crucial for credit unions as...more

Holland & Knight LLP

NHTSA in the Second Trump Administration

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The National Highway Traffic Safety Administration (NHTSA) is charged with establishing safety and fuel economy standards for motor vehicles and promoting overall highway traffic safety....more

Holland & Knight LLP

Biden Administration's Blocking Order Sparks Legal Battles

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President Joe Biden on Jan. 3, 2025, issued a blocking order (the Order) addressing the proposed acquisition of United States Steel Corporation (U.S. Steel) by Nippon Steel Corporation (Nippon Steel), Japan's largest...more

Troutman Pepper Locke

The Growing Role of State AGs in AI Regulatory & Enforcement Issues — The Good Bot Podcast

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Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment of The Good Bot, Brett is joined by partners...more

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