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Mayer Brown

FAQs on Proposed Reforms to the UK Senior Managers and Certification Regime

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The Senior Managers & Certification Regime ("SM&CR") has been a cornerstone of the UK’s individual accountability regulatory framework for banks, insurers and other regulated firms since its introduction in the wake of the...more

Walkers

ESMA's findings on sustainability risk integration and disclosures: What you need to know

Walkers on

ESMA has published its final report on the CSA on the integration of sustainability risks and disclosures in the investment fund sector and a thematic note on sustainability-related claims focusing on ESG credentials. ...more

A&O Shearman

ECB and AMLA sign MoU to strengthen EU AML supervision

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The European Central Bank (ECB) has published a Memorandum of Understanding (MoU) (dated 27 June) that the ECB has entered into with the European Union's Anti-Money Laundering Authority (AMLA) to enhance cooperation between...more

Foley & Lardner LLP

SEC and CFTC Extend Form PF Compliance Date Again

Foley & Lardner LLP on

On June 11, 2025 the Securities and Exchange Commission (SEC) and Commodity Futures Trading Commission (CFTC) again extended the compliance date for the most recent Form PF amendments, providing a near four-month reprieve for...more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

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In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

A&O Shearman

BoE renews statement of commitment

A&O Shearman on

The Bank of England (BoE) has announced it has renewed its statement of commitment to the FX Global Code, based on the revised code dated December 2024. The FX Global Code outlines principles of good practice in the foreign...more

A&O Shearman

Regulatory monitoring: EU version - June 2025

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Our monthly regulatory newsletter monitors all relevant developments regarding European regulatory law in English language....more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

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On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

McDermott Will & Emery on

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

DLA Piper

Texas Adopts the Responsible AI Governance Act

DLA Piper on

On June 22, 2025, Governor Abbott signed HB 149, the “Texas Responsible Artificial Intelligence Governance Act” (the Act or TRAIGA), making Texas the third US state, after Colorado and Utah, to adopt a comprehensive...more

Thomas Fox - Compliance Evangelist

2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition

What happens when two top compliance commentators get together? They talk compliance, of course. Join Tom Fox and Kristy Grant-Hart in 2 Gurus Talk Compliance as they discuss the latest compliance issues in this week’s...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

A&O Shearman

FCA launches IAAT

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The UK Financial Conduct Authority (FCA) has launched the investment advice assessment tool (IAAT) to help personal investment firms assess the suitability of their investment advice and disclosures to consumers (excluding...more

White & Case LLP

AI Watch: Global regulatory tracker - Brazil (UPDATED)

White & Case LLP on

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

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

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

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

Health Care Compliance Association (HCCA)

Healthcare Enterprise Risk Management

Risk assessments are not new in healthcare, and in specific regulatory areas are required. But, that doesn’t mean things aren’t changing. More and more organizations are embracing enterprise risk assessments (ERM) as a way...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Conyers

Understanding Outsourcing Obligations for Cayman Islands Funds

Conyers on

It has been two years since the Cayman Islands Monetary Authority (CIMA) introduced its Rule on Corporate Governance for Regulated Entities (the “Corporate Governance Rule”), and a year and a half since it came into force....more

Alston & Bird

5 Things to Think About When Using AI

Alston & Bird on

What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

Ropes & Gray LLP

Five Takeaways From the EU Commission’s AI Literacy Q&As

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Earlier this month, the European Commission released AI Literacy – Questions & Answers. The Q&As are a useful primer — both for organisations at the start of their literacy journey and those that, having taken steps to...more

White & Case LLP

AI Watch: Global regulatory tracker - OECD

White & Case LLP on

The OECD's AI recommendations encourage Member States to uphold principles of trustworthy AI. Status of the AI Regulations - The Adherents have agreed to promote, implement, and adhere to the Recommendation. The Principles...more

Davis Wright Tremaine LLP

CFTC Divisions Issue Staff Advisory on Referrals to Division of Enforcement

On April 17, 2025, the Market Participants Division, the Division of Clearing and Risk, and the Division of Market Oversight (collectively, the "Operating Divisions") of the CFTC, along with the Division of Enforcement...more

A&O Shearman

SRB consultation on expectations on valuation capabilities

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The Single Resolution Board (SRB) has published a press release confirming it had launched a public consultation on its expectations on valuation capabilities (dated 1 April). The consultation forms part of the Single...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

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