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Regulatory Oversight New Guidance

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

Mitchell, Williams, Selig, Gates & Woodyard,...

Transportation/Hazardous Materials: Pipeline and Hazardous Materials Safety Administration Interpretive Letter Addressing Wet...

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in a June 10th interpretive letter the application of Hazardous Materials Regulations (“HMR”) applicable to wet batteries...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

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

ArentFox Schiff

USPTO Expands on ‘Settled Expectations’ as Basis for PTAB Discretionary Denials

ArentFox Schiff on

The US Patent and Trademark Office (USPTO) recently issued a Director Discretionary Denial decision expanding on the “settled expectations” ground for discretionary denial of a post-grant review proceeding...more

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...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

Goodwin

The Evolving Landscape of AI Regulation in Financial Services

Goodwin on

Artificial intelligence (AI) is increasingly woven into financial services operations, transforming everything from consumer interactions through chatbots and targeted marketing to essential functions like underwriting,...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

Katten Muchin Rosenman LLP

SEC Staff Green Lights Various Staking Activities

The Securities and Exchange Commission’s (SEC) Division of Corporation Finance released a statement articulating its position that certain cryptocurrency staking activities fall outside the federal securities laws. This...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

Brownstein Hyatt Farber Schreck

DOJ Issues New Guidance on White-Collar Prosecutions and Corporate Monitors

On May 12, 2025, the current head of the Department of Justice’s (DOJ) Criminal Division issued fresh guidance to all personnel under his purview with new two memoranda....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

Orrick, Herrington & Sutcliffe LLP

FHA archives nearly 600 inactive mortgagee letters

On May 19, it was reported that the FHA’s Office of Single Family Housing (OSFH) archived nearly 600 inactive mortgagee letters after determining that their inclusion on OSFH’s website caused confusion among lenders seeking...more

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