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Wilson Sonsini Goodrich & Rosati

Association of State Financial Regulators Issues Guidance on Virtual Currency for Licensed Money Transmitters

Recognizing the evolving landscape of digital finance, the Conference of State Bank Supervisors (CSBS), an association of state financial regulators, issued advisory guidance on the treatment of virtual currency held on a...more

A&O Shearman

FCA to launch new and improved Handbook website

A&O Shearman on

The UK Financial Conduct Authority (FCA) has announced its plan to launch a new and improved FCA Handbook website as part of its five-year strategy to enhance regulatory efficiency...more

Troutman Pepper Locke

CSBS Issues Guidance on Virtual Currency and Tangible Net Worth

Troutman Pepper Locke on

On June 26, the Conference of State Bank Supervisors (CSBS) released new guidance regarding the treatment of virtual currency in the calculation of a licensee’s tangible net worth under the Money Transmission Modernization...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Hogan Lovells

FDA Finalizes Guidance on Conducting Remote Regulatory Assessments

Hogan Lovells on

The Food and Drug Administration (FDA) published its final guidance for industry entitled “Conducting Remote Regulatory Assessments – Questions and Answers” on June 26, 2025. Initially published in draft format in July 2022...more

ArentFox Schiff

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

ArentFox Schiff on

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

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Ropes & Gray LLP

The FCA's 2024/2025 Annual Report on whistleblowing is out - here's what you need to know

Ropes & Gray LLP on

On Tuesday (24 June 2025) the FCA published its Prescribed Person’s Annual Report on whistleblowing (“24/25 Report”), which covers reports received and acted on with during the period 1 April 2024 – 31 March 2025 (the “24/25...more

Walkers

ESMA principles on third-party risk supervision

Walkers on

On 12 June 2025, ESMA published its principles on third-party risk supervision which are designed to assist supervisory authorities to identify, assess and supervise the third-party risks of EU entities operating across the...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

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Morgan Lewis - As Prescribed

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...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

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

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

Jones Day

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

Jones Day on

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

Alston & Bird

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

Alston & Bird on

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

Mayer Brown Free Writings + Perspectives

SEC Division of Trading and Markets Releases FAQs on Crypto Asset Activities and Distributed Ledger Technology; 2019 Joint Staff...

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

McGuireWoods LLP

Banks May Provide Cryptocurrency Transaction and Custody Services, but OCC Has Yet to Provide Clear Compliance Requirements

McGuireWoods LLP on

On May 7, 2025, the Office of the Comptroller of the Currency (“OCC”) issued a follow up to its July 2020 Interpretative Letter 1170, which allowed national banks to provide cryptocurrency custody services to their customers....more

A&O Shearman

ESMA final guidelines on preventing and detecting market abuse under MiCAR

A&O Shearman on

The European Securities and Markets Authority (ESMA) has published its final report on the guidelines on supervisory practices for National Competent Authorities (NCAs) to prevent and detect market abuse under the Market in...more

Vedder Price

SEC Division of Corporation Finance Staff Issues Guidance on Crypto Assets

Vedder Price on

As previously summarized here, since SEC Commissioner Mark T. Uyeda was named Acting Chairman on January 21, 2025, the SEC has significantly shifted its approach to cryptocurrency regulation and enforcement actions, including...more

Carlton Fields

NAIC Life and Annuity Illustration Subgroup and Suitability Working Group Construct More Guidance

Carlton Fields on

At the NAIC Spring National Meeting, the Illustration Subgroup and the Suitability Working Group reported that they are building out the following additions...more

A&O Shearman

FCA announces changes to simplify supervisory communications

A&O Shearman on

The UK Financial Conduct Authority (FCA) has announced it will no longer be issuing and publishing portfolio letters from 30 April. Instead, these will be replaced with a small number of market reports. The market reports...more

Miles & Stockbridge P.C.

Fannie Mae Updates Preferred Equity Guidelines: What You Need to Know

Fannie Mae published its Preferred Equity Guide Update (25-06) and its Preferred Equity Checklist (Form 6441) in mid-April. Although unpublished iterations have been circulating for the past two years, lenders and law firms...more

Orrick, Herrington & Sutcliffe LLP

OMB issues guidance for implementing executive order on agency accountability

On April 17, the Office of Management and Budget (OMB) issued a memorandum providing guidance for historically independent regulatory agencies to comply with regulatory provisions in Executive Order (EO) 14215. The EO “seeks...more

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