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Sheppard Mullin Richter & Hampton LLP

FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more

DLA Piper

EU: EDPB Opinion on AI Provides Important Guidance Though Many Questions Remain

DLA Piper on

A much-anticipated Opinion from the European Data Protection Board (EDPB) on AI models and data protection has not resulted in the clear or definitive guidance that businesses operating in the EU had hoped for. The Opinion...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Seyfarth Shaw LLP

New Year, New Penalties: OSHA and USEPA Increase Penalties

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The federal Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (“EPA”) have published their 2025 increases to civil penalties....more

Faegre Drinker Biddle & Reath LLP

PBGC Issues Technical Update on Accelerated Due Date for 2025 Premium Filings

The Pension Benefit Guaranty Corporation (PBGC) has issued its first technical update of the year to provide guidance on the accelerated premium filing date for plan years that begin in 2025. As required by a provision in the...more

Holland & Knight LLP

Treasury Department, IRS Release Section 45Z Clean Fuel PTC Guidance

Holland & Knight LLP on

The U.S. Department of the Treasury and IRS released initial guidance on Jan. 10, 2025, regarding the production tax credit (PTC) for clean fuels under Section 45Z of the Internal Revenue Code, as enacted by the Inflation...more

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....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

White & Case LLP

Navigating the New UK Antitrust Landscape

White & Case LLP on

The UK's Competition and Markets Authority (CMA) has published a suite of guidance documents that set out how it intends to exercise its powers under the Digital Markets, Competition, and Consumers Act (Act). The Act, which...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

McCarter & English Blog: Government Contracts...

Antitrust Corporate Compliance Programs: Late 2024 Changes Mean Companies Should Revisit Their Programs Early in 2025

The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division...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

Fisher Phillips

Top 6 Employer Takeaways From New EEOC Wearable Tech Guidance

Fisher Phillips on

Wearable technologies are becoming increasingly common in the workplace, but a new guidance document from the Equal Employment Opportunity Commission (EEOC) has made it clear that employers need to tread carefully. From smart...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

Troutman Pepper Locke

FERC Issues Final Rule on Clean Water Act Section 401 Water Quality Certification Requirements

Troutman Pepper Locke on

On November 21, 2024, the Federal Energy Regulatory Commission (“FERC”) issued a final rule establishing a categorical one-year “reasonable period of time” for certifying authorities to act on requests for water quality...more

DLA Piper

Digital Transformation: eSignature and ePayment News and Trends - November/December 2024

DLA Piper on

Today’s ever-shifting business environment means that consumers, businesses, employers, and employees all expect to transact digitally. To remain efficient and competitive, companies must digitally transform their businesses....more

Health Care Compliance Association (HCCA)

Compliance should promote the hotline

At a recent HCCA event, large digital signs throughout the conference venue displayed a toll-free number and the message, “If you see something, say something.” The message served as a great reminder that healthcare...more

McDermott Will & Emery

Global Equity and Employment Law Considerations for 2025

Many countries finalized new regulations and released new guidance in 2024 regarding global equity plans. Multinational companies should confirm whether their equity grant materials and plan administration align with such...more

Nutter McClennen & Fish LLP

Nutter Bank Report: December 2024

CFPB Imposes $5 Cap on Overdraft Fees Charged by Large Banks - The CFPB has adopted a final rule capping overdraft fees at $5 for banks and other depository institutions with more than $10 billion in assets (covered...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

Sheppard Mullin Richter & Hampton LLP

CFPB Report Highlights Widespread Violations in Student Loan Sector

On December 16, the CFPB released a special edition of its Supervisory Highlights, which detailed findings from the Bureau’s recent examinations of student loan markets. The report identifies a range of violations related to...more

Quarles & Brady LLP

FDA Releases Declaratory Order Regarding Tirzepatide Shortage

Quarles & Brady LLP on

The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more

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