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Mintz - Employment Viewpoints

DOL Issues Opinion Letter Clarifying Intersection of FMLA and State or Local Paid Family and Medical Leave Benefits

Shortly before the Trump Administration started, the U.S. Department of Labor (DOL) issued an opinion letter clarifying the “substitution” provision under the federal Family and Medical Leave Act (FMLA) when it intersects...more

Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more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

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...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FDA Releases Draft Guidance on the Labeling of Plant-Based Foods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The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Alston & Bird on

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

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

Alston & Bird

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

Alston & Bird on

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

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

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

Holtzman Vogel Baran Torchinsky & Josefiak

In-Compliance: December 2024 Round-Up

A Lookback at the Federal Election Commission in 2024 by: Matt Petersen - Now that the presidential election has concluded and 2024 is drawing to a close, it is worth looking back at one of the most consequential years for...more

Nutter McClennen & Fish LLP

Beverage Breakdown (December 2024)

Welcome to Nutter's Beverage Breakdown, a periodic legal update on developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. ...more

Lathrop GPM

OIG Issues New Nursing Facility Compliance Guidance, Comes on the Heels of Enhanced Medicare Enrollment Requirements for SNFs

Lathrop GPM on

The Office of Inspector General at the U.S. Department of Health and Human Services (OIG) recently followed up on a 2023 commitment to supplement its General Compliance Program Guidance (GCPG) by publishing its first...more

Latham & Watkins LLP

Recent Developments for UK PLCs - December 2024

Latham & Watkins LLP on

On 15 November 2024, the FCA released Primary Market Bulletin 52, offering guidance on compliance with MAR and DTR requirements, particularly in identifying and disclosing inside information, managing shareholder...more

King & Spalding

OIG Issues Nursing Facility Compliance Guidance

King & Spalding on

On November 20, 2024, OIG released new compliance program guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (the Nursing Facility ICPG or the Guidance). The...more

Ankura

Navigating the New Digital Currency Guidelines in Hawaii: Opportunities for Fintech Innovation

Ankura on

The recent issuance of guidance regarding digital currency activities in Hawaii marks a significant milestone for Fintech companies and startups operating in or considering expansion into the Aloha State. Effective July 1,...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

Venable LLP on

Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

Kohn, Kohn & Colapinto LLP

Honest Corporate Disclosure Dims Under New DOJ Evaluation of Corporate Compliance Programs

In September 2024, the U.S. Department of Justice (DOJ) published an updated Evaluation of Corporate Compliance Programs to provide a roadmap for companies on how to run their internal compliance to avoid prosecution,...more

WilmerHale

UK Government Publishes Guidance on New Failure to Prevent Fraud Offence

WilmerHale on

On 6 November 2024, the UK Government published the much-anticipated guidance on the new corporate offence of failure to prevent fraud (the “Guidance”). The failure to prevent fraud offence forms part of a huge shift in the...more

Venable LLP

OFAC Issues Sanctions Compliance Guidance and Scenarios for U.S. and International Maritime Industry

Venable LLP on

On October 31, 2024, the U.S. Treasury Department's Office of Foreign Assets Control (OFAC) issued scenario-based guidance specific to the maritime shipping industry....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

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