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AI Literacy: A Compliance Need and a Training Necessity

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The European Union recently published guidance on the training that companies should provide to employees to achieve “AI literacy” required under the EU AI Act – and like so much else about artificial intelligence these days,...more

Morgan Lewis - As Prescribed

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

Jackson Lewis P.C.

New DOL/EBSA Opinion Letter Program Offers A Path to Clarity for Plan Sponsors

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On June 2, 2025, the U.S. Department of Labor (DOL) announced a significant expansion of its compliance assistance tools by launching an Opinion Letter Program across five key enforcement agencies, including the Employee...more

Seward & Kissel LLP

What We Have Here Is a Success to Communicate: SEC Releases FAQs for BDs and Transfer Agents Relating to Crypto Asset Activities...

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On May 15, 2025, the staff of the Division of Trading and Markets (the “Staff”) of the Securities and Exchange Commission (“Commission”) released responses to frequently asked questions (“FAQs”) relating to crypto assets and...more

BakerHostetler

DSIR Deeper Dive: Artificial Intelligence - Banner Years (and Counting) for AI Guidance and Regulation

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The period of 2024-2025 was significant for AI law, regulation, and guidance, beginning in early February 2024, and the news told the tale...more

Seyfarth Shaw LLP

“Dear DOL”: Labor Department Re-Launches Opinion Letter Program

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In a welcome development for employers navigating complex federal employment laws, the U.S. Department of Labor has announced the re-launch of its opinion letter program across several agencies, including the Wage and Hour...more

Ropes & Gray LLP

The FCA Has Revamped its Enforcement Guide – Here’s What You Should Know

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On Tuesday the UK’s Financial Conduct Authority (FCA) issued an updated version of its Enforcement Guide, which will now be referred to as ‘ENFG’ in the FCA Handbook, to distinguish it from the previous version. The ENFG is...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Fenwick & West LLP

SEC Staff Statement Concludes Protocol Staking Is Not a Securities Transaction

Fenwick & West LLP on

On May 29, 2025, the SEC’s Division of Corporation Finance (Corp Fin) released a Statement on Certain Protocol Staking Activities clarifying that certain crypto asset staking activities on proof-of-stake (PoS) blockchain...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

New York State Releases Guidance on Retail Worker Safety Act

The New York Retail Worker Safety Act is now in effect as of June 2, 2025. Following months of anticipation and planning, covered employers in New York State will now have to comply with the act’s workplace violence...more

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

King & Spalding

CMS Issues New Guidance and Request for Information on Hospital Price Transparency Regulations

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Last week, CMS published new guidance and issued a Request for Information on the Hospital Price Transparency Rule in response to President Trump’s February 25, 2025 Executive Order titled, “Making America Healthy Again by...more

Seyfarth Shaw LLP

New York Releases FAQs, Model Training, and Model Policy for Retail Workplace Violence Prevention Law

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A workplace violence prevention law passed by the New York State legislature in June 2024, signed into law by the Governor in September 2024, and amended in February 2025 is set to take effect in part on June 2, 2025. On May...more

Jones Day

Crypto Staking: SEC Staff Clarifies Non-Security Status for Certain Protocol Activities

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A May 29, 2025, U.S. Securities and Exchange Commission ("SEC") Division of Corporation Finance statement explains that "Covered Crypto Assets"—crypto tokens without any inherent rights to passive income, business enterprise...more

Mintz

California Provides Additional Guidance on Mandatory Climate Disclosures

Mintz on

On May 29, 2025, the California Air Resources Board delivered a presentation that provided additional details concerning the soon-to-be implemented mandatory climate disclosures. Perhaps most significantly, the California...more

Holland & Knight LLP

DOD Secretary Directs Limitation of IT Consulting and Advisory Services Contracts

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Contractors Should Seek to Distinguish Themselves in More Competitive Environment - The U.S. Department of Defense (DOD) on May 27, 2025, issued a memorandum implementing Executive Order (EO) 14222. As Holland & Knight...more

Parker Poe Adams & Bernstein LLP

Department of Transportation English Proficiency Guidance Takes Effect in Late June

Last month, President Donald Trump signed an executive order directing the Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) to begin enforcement of English language proficiency (ELP)...more

Jones Day

CFTC Divisions Interpret "U.S. Person" Definition and U.S. Location Versus Foreign Location

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A 2024 CFTC enforcement action settlement that may have introduced a new test for when the Commodity Exchange Act and the agency's regulations apply on a cross-border basis concerned then-CFTC Commissioner and now Acting CFTC...more

Conn Maciel Carey LLP

New York DOL Releases Guidance on the Retail Worker Safety Act

Conn Maciel Carey LLP on

On May 29, 2025, the New York State Department of Labor (NYDOL) published Frequently Asked Questions (FAQs), a template retail workplace violence prevention policy, and model training materials regarding the Retail Worker...more

K&L Gates LLP

United States: SEC’s Division of Trading and Markets Issues Crypto Asset-Related FAQs (And Withdraws Previous Guidance)

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On 15 May 2025, the US Securities and Exchange Commission’s Division of Trading and Markets (Division) released Frequently Asked Questions (FAQs) clarifying how certain broker-dealer and transfer agency rules relate to crypto...more

Holland & Knight LLP

DOD Secretary Directs Limitation of IT Consulting and Advisory Services Contracts

Holland & Knight LLP on

The U.S. Department of Defense (DOD) on May 27, 2025, issued a memorandum implementing Executive Order (EO) 14222. As our team previously summarized, EO 14222 implemented the Department of Government Efficiency's (DOGE) "cost...more

Proskauer - Employee Benefits & Executive...

DOL Rescinds 2022 Guidance Cautioning Against 401(k) Plan Investments in Cryptocurrencies

On May 28, 2025, the Department of Labor (“DOL”) issued Compliance Assistance Release No. 2025-01 which rescinds the DOL’s prior Compliance Assistance Release No. 2022-1 which had warned 401(k) plan fiduciaries against adding...more

Schwabe, Williamson & Wyatt PC

FAR Council Using Systematic Approach to Make Revisions

The FAR Council is undertaking a systematic approach to revising the FARs. It recently released its revisions to FAR Part 10, Market Research. The GSA provided the following explanation of the changes to FAR Part 10: ...more

Alston & Bird

CFTC Guidance Clarifies Non-U.S. Person Status of Certain Offshore Trading Firms

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Our Investment Funds Team examines an interpretive letter from the Commodity Futures Trading Commission (CFTC) that may help to clarify when non-U.S. firms with U.S. contacts can be considered non-U.S. persons for...more

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