News & Analysis as of

Regulatory Oversight

DLA Piper

Time to Reassess The Definition of a Foreign Private Issuer?

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As discussed at an open meeting held on June 4, 2025, the US Securities and Exchange Commission (Commission) published a concept release (Release) soliciting comments on whether to revise the definition of “foreign private...more

White & Case LLP

AI Watch: Global regulatory tracker - Brazil (UPDATED)

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Brazil intends to regulate AI through Bill No. 2,338/2023 ("Brazil's Proposed AI Regulation"), although there are currently no specific codified laws, statutory rules or regulations in Brazil that directly regulate AI....more

A&O Shearman

The FCA’s revised Enforcement Guide: Key policy changes to be aware of

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The UK Financial Conduct Authority (FCA) has updated its Enforcement Guide, including its revised policy on when it will announce details of enforcement investigations. Following a consultation process that was subject to...more

Moore & Van Allen PLLC

The Desk: June Edition

While there was some—albeit limited—Enforcement activity in May (click here for last month’s enforcement actions), in this month’s Round-Up we want to highlight some updates that suggest the Enforcement front may continue to...more

Sheppard Mullin Richter & Hampton LLP

FDIC and Maryland End Joint Consent Orders Against Regional Bank

On April 7, the FDIC and the Maryland Office of Financial Regulation terminated two consent orders against a regional bank headquartered in Maryland. The termination concludes joint federal and state enforcement actions that...more

Herbert Smith Freehills Kramer

UK Securitisation Framework Update

The UK Securitisation Framework came into force on 1 November 2024 and revoked the previous EU legislation that had been retained under UK law ("Previous UK SR"). The new regime represents a significant shift in the way that...more

Bergeson & Campbell, P.C.

President Signs EO to Restore Gold Standard for Science, Calls for Reevaluation of Biden Administration’s Scientific Integrity...

On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to...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

Fox Rothschild LLP

At Stake - June 5, 2025

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The Illinois Gaming Board (IGB) held its monthly meeting on Thursday, June 5, 2025. The meeting was hybrid with in-person accessibility at 160 N. LaSalle St., 5th Floor Auditorium and availability via livestream. Board...more

Carlton Fields

U.S. Supreme Court Denies Alpine’s Petition Challenging Constitutionality of FINRA Enforcement Proceedings

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On June 2, 2025, the U.S. Supreme Court denied a petition for writ of certiorari filed by Alpine Securities Corp. in Alpine Securities Corp. v. Financial Industry Regulatory Authority. In doing so, the Supreme Court declined...more

Snell & Wilmer

Banned, Fined, and Redefined: The 2025 State Crackdown on Online Sweepstakes

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Recent events around the country indicate that online sweepstakes are facing increasing scrutiny and concerns from legislatures, regulators and others. “Montana just criminalized everyday digital promotions with a law so...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Barnea Jaffa Lande & Co.

DORA for Tech Vendors - What You Should Know (But Haven’t Asked)

DORA (Digital Operational Resilience Act) is an EU regulation that sets rules for how financial entities manage ICT (Information and Communication Technology) risks. It covers areas like cyber resilience, incident reporting,...more

Foodman CPAs & Advisors

The Compliance Gap in AML AI: Why Audit-Ready Tools Matter

icraAs artificial intelligence reshapes financial compliance practices, regulators across Latin America and globally are increasing their scrutiny of AI-based AML tools. This article explores the growing audit gap, and what...more

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

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On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....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

A&O Shearman

Regulatory monitoring: EU Version - May 2025

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The study on enhancing EU competitiveness in the banking sector, requested by the ECON, has been published by the Economic Governance and EMU Scrutiny Unit. The study emphasises the importance of a resilient and efficient...more

A&O Shearman

Regulatory monitoring - May 2025

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The study on enhancing EU competitiveness in the banking sector, requested by the ECON, has been published by the Economic Governance and EMU Scrutiny Unit. The study emphasises the importance of a resilient and efficient...more

A&O Shearman

IOSCO final report and guidance for liquidity risk management for CIS

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The International Organization of Securities Commissions (IOSCO) has published its final report containing revised recommendations for liquidity risk management for collective investment schemes (CIS), accompanied by...more

BCLP

Hong Kong Stablecoins Bill passed by LegCo

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Stablecoins are cryptocurrencies with values tied to fiat currencies or other assets, and are often said to be “pegged to” a single or a basket of fiat currents and/or other assets....more

Latham & Watkins LLP

FCA Publishes Final Policy Position on Announcing Enforcement Investigations

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The regulator has dropped its proposed “public interest” test, but will take certain aspects of its proposals forwards. On 3 June 2025, the FCA published its final policy (PS25/5) on announcing enforcement...more

Akin Gump Strauss Hauer & Feld LLP

FCC Voted To Adopt New Items on Foreign Ownership Requirements and Spectrum Use in the 12.7 GHz and 42 GHz bands at Its May 22...

The Federal Communications Commission (FCC) held its May Open Meeting on Thursday, May 22, during which it voted to adopt three items: (1) a Notice of Proposed Rulemaking (NPRM) that proposes to require holders of certain...more

Husch Blackwell LLP

FMC to Examine Vessel Flagging Laws and Practices

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The Federal Maritime Commission (FMC) recently announced it was launching a non-adjudicatory investigation into whether foreign vessel flagging laws and practices create unfavorable shipping conditions for the U.S. trade. The...more

Jones Day

Congress Introduces CLARITY Act to Establish Digital Asset Regulatory Framework

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U.S. House lawmakers introduced the bipartisan CLARITY Act of 2025 proposing a comprehensive regulatory framework for digital assets that would delineate agencies' oversight roles, establish a provisional registration regime...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

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