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Regulatory Agenda New Guidance Regulatory Requirements

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

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Key Takeaways: - The FDA Human Foods Program (HFP) released its agenda for releasing draft guidance for the remainder of 2025.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

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more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

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 & Schulte

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

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

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

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

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

Sheppard Mullin Richter & Hampton LLP

Key Takeaways from the DOJ Antitrust Division’s Updated Compliance Guidance: It’s Not Just Criminal Anymore

The Department of Justice’s Antitrust Division (“Antitrust Division”) recently updated its Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations guidance document (“Antitrust Compliance Guidance”)....more

A&O Shearman

CFTC announces final guidance regarding voluntary carbon credit derivative contracts

A&O Shearman on

On September 20, 2024, the U.S. Commodity Futures Trading Commission (“CFTC”) announced that it had approved final guidance (the “Final Guidance”) for designated contract markets (“DCMs”) that list voluntary carbon credit...more

Troutman Pepper Locke

FDIC and OCC Finalize New Guidelines on Bank Mergers

Troutman Pepper Locke on

Yesterday, both the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC) finalized new guidelines regarding bank mergers. According to the agencies, these updates aim to enhance...more

White & Case LLP

What’s New - Inflation Reduction Act Final PWA Regulations Published

White & Case LLP on

On June 18, 2024, the Internal Revenue Service (IRS) published its Final Regulations on the Inflation Reduction Act Prevailing Wage requirements ("Final Regulations"). While the Final Regulations generally adhere to the prior...more

A&O Shearman

Bit by bit: improving consumer complaint processes in crypto

A&O Shearman on

On May 30, 2024, the New York State Department of Financial Services ("NYSDFS" or the "Department") issued guidance to all virtual currency businesses licensed or chartered with the Department ("VCEs"), including those...more

Womble Bond Dickinson

Nevada Gaming Control Board Issues Gaming Technology Approval Guidelines

Womble Bond Dickinson on

In May 2024, the Nevada Gaming Control Board (“Board”) released a notice to licensees encouraging the introduction and use of new and innovative technology into the gaming industry in Nevada. To achieve this objective, the...more

Mintz - Antitrust Viewpoints

USPTO Issues Guidance on AI Use to Patent Professionals — AI: The Washington Report

Pursuant to President Biden’s October 2023 executive order on AI, on April 11, 2024, the United States Patent and Trademark Office (USPTO or Office) published “Guidance on Use of Artificial Intelligence-Based Tools in...more

Seward & Kissel LLP

SEC Provides Guidance on Determining Investment Company Status in SPAC Rule Release

Seward & Kissel LLP on

Who may be interested: Registered Investment Companies, SPACs, Investment Advisers Quick Take: Following a 3-2 vote, the SEC adopted final rules to enhance disclosure and provide additional investor protections in IPOs by...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Capital Ratio: Roundup of Upcoming UK Regulatory Reforms for Financial Institutions

UK regulators have recently announced a number of reforms for banks and other financial institutions. - On 23 November 2023, the Prudential Regulation Authority (PRA) and the Financial Conduct Authority (FCA) (together,...more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

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