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Regulatory Oversight Regulatory Requirements New Guidance

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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more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

Ballard Spahr LLP

OCC, FDIC eliminating ‘reputational risk’ from supervision, examinations

Ballard Spahr LLP on

The OCC has removed “reputational risk” from its handbooks and guidance and the FDIC is moving to do the same. ...more

Morgan Lewis

CFTC Staff Issue Advisory on Criteria for Referrals to the Division of Enforcement

Morgan Lewis on

The staff of the US Commodity Futures Trading Commission (CFTC or Commission) on April 17, 2025 issued an advisory outlining the criteria the agency’s Market Participants Division, Division of Clearing and Risk, and Division...more

A&O Shearman

EPC publishes Guidelines for PSPs joining payment schemes

A&O Shearman on

The European Payments Council (EPC) has issued Version 7.0 of the Adherence Guide to the EPC Payment Schemes, together with an updated webpage. The updated guide provides guidelines and template application forms for payment...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

Perkins Coie

White House Unveils Updated AI Guidelines for Federal Agencies

Perkins Coie on

Key Takeaways - - The White House's Office of Management and Budget (OMB) has issued two new memorandums, which establish new federal policies for the use and acquisition of artificial intelligence (AI) by the federal...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Flaster Greenberg PC

SEC Offers Updated Guidance for Rule 506(c) Private Placements

Flaster Greenberg PC on

On March 12, 2025, the SEC published a No-Action Letter clarifying accredited investor verification requirements under Rule 506(c)....more

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

Rivkin Radler LLP on

In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

A&O Shearman

SRB consultation on operational guidance on resolvability testing for banks

A&O Shearman on

The Single Resolution Board (SRB) has opened a consultation on its operational guidance on resolvability testing for banks under the SRB's remit. It aims to ensure that European banks are regularly testing their capabilities...more

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