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New Guidance Regulatory Agenda

Skadden, Arps, Slate, Meagher & Flom LLP

SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation

Introducing “SkadBytes,” our newest podcast where Skadden’s IP and Tech team discusses pivotal changes driving tech regulation and innovation. Host Deborah Kirk and colleagues Alistair Ho and Jonathan Stephenson reflect on...more

Perkins Coie

FDA Human Foods Program Details 2025 Guidance Agenda: Key Topics and Priorities

Perkins Coie on

Key Takeaways: - The FDA Human Foods Program (HFP) released its agenda for releasing draft guidance for the remainder of 2025. - The agenda includes new guidance on topics such as new dietary ingredient notifications, food...more

Hogan Lovells

What is an AI System? The EU Commission’s guidance

Hogan Lovells on

On February 6, 2025, the European Commission published guidelines clarifying the definition of an “AI system” under the EU AI Act. Only systems that meet this definition fall within the AI Act’s scope, making it a key...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

Akin Gump Strauss Hauer & Feld LLP

CryptoLink - May 2025

In May 2025, the leadership from the SEC provided guidance on digital asset regulation in several keynote addresses and round tables. The SEC's activities in May 2025 suggest a deliberate movement towards establishing a more...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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

DLA Piper

China: CAC Publishes Official Q&As for Cross-Border Data Transfer Regulation

DLA Piper on

The Cyberspace Administration of China (CAC) released an important Q&A on cross-border data transfer requirements and policies in early April, providing clarification on a number of issues of concern to companies in China....more

Gibney Anthony & Flaherty, LLP

What Student Visa Holders and Employers Need to Know About Recent Student Visa Rescissions and Increased Scrutiny

The Department of State (DOS) has recently increased scrutiny of existing student visa holders and those requesting new student visas at U.S. consulates abroad. Some F-1 visas and SEVIS records have been rescinded or...more

Fenwick & West LLP

Entertainment or Investment? The SEC’s Stance on Meme Coins as Securities

Fenwick & West LLP on

On February 27, 2025, the Securities and Exchange Commission’s (SEC) Division of Corporation Finance (Corp Fin) published a new staff statement intended to clarify the application of federal securities laws to meme coins....more

Schwabe, Williamson & Wyatt PC

NEPA’s Future Comes Into View with New Guidance and Rule Recission ‎

The past few months have been a period of high uncertainty over implementation of the National Environmental Policy Act (NEPA). In December, the Supreme Court heard arguments in a case that addressed the scope of foreseeable...more

Kerr Russell

CTA Enforcement Reinstated with New Compliance Deadlines

Kerr Russell on

The U.S. District Court for the Eastern District of Texas has stayed the last remaining nationwide injunction against enforcement of the Corporate Transparency Act (CTA) in Smith v. U.S. Department of the Treasury....more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Skadden, Arps, Slate, Meagher & Flom LLP

PRA and FCA Offer New Guidance on How Changes in Control Will Be Assessed

On 1 November 2024, the UK Prudential Regulation Authority (PRA) and Financial Conduct Authority (FCA) published a joint policy statement (PS 18/24) on the prudential assessment of acquisitions and increases in control. The...more

Holland & Knight LLP

U.S. Department of Education Focuses on Misrepresentation by Higher Education, Partners

Holland & Knight LLP on

In the final days of the Biden Administration, the U.S. Department of Education (ED) announced a number of policy initiatives and enforcement actions related to ED's misrepresentation regulations for institutions of higher...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Troutman Pepper Locke

New Jersey AG Platkin Announces New Guidance on AI Use

Troutman Pepper Locke on

On January 9, New Jersey Attorney General (AG) Matthew J. Platkin and the Division on Civil Rights (DCR) launched a new Civil Rights and Technology Initiative aimed at addressing the potential for discrimination and bias...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

ArentFox Schiff

Back to the Antitrust Basics: FTC and DOJ Call for Case-by-Case Enforcement With the Withdrawal of Longstanding Competitor...

ArentFox Schiff on

With the US Department of Justice (DOJ) and Federal Trade Commission (FTC) withdrawing yet another set of antitrust compliance guidelines last month, companies that collaborate with their competitors — whether directly or...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

Wiley Rein LLP on

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Skadden, Arps, Slate, Meagher & Flom LLP

ESG: A Review of 2024 and Key Trends To Look for in 2025

In this article, we reflect on key trends in ESG over the second half of 2024 and look ahead at trends that may emerge in 2025. We analyze developments in the latter half of 2024, which were similar to those highlighted in...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Brooks Pierce

Counting Down to the New Year: Ten “Need-to-Know” Labor and Employment Developments of 2024

Brooks Pierce on

2024 was yet another active year in the labor and employment landscape. While 2025 and the new administration could bring any number of changes to workplace laws and enforcement, the timing and extent of such changes is...more

A&O Shearman

HKMA guideline on Digital Bond Grant Scheme

A&O Shearman on

On November 28, 2024, the Hong Kong Monetary Authority (HKMA) published the guideline on Digital Bond Grant Scheme (DBGS). As acknowledged in the 2024 Policy address, the DBGS is part of the Hong Kong Government and HKMA’s...more

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