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Category Archives: Compliance

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Compliance

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. The FDA stated that this new inspection strategy will ensure that foreign manufacturers receive the… Continue Reading
Compliance, Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims, Government Contracts

Department of Justice Suggests “Aggressive” Enforcement of False Claims Act

In a speech to the Federal Bar Association’s annual qui tam conference on Feb. 20, 2025, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice, discussed how the Trump administration plans to “aggressively” enforce the False Claims Act (FCA). His statements come on top of other comments from Trump… Continue Reading
Compliance, Fraud, Deception and False Claims

State Attorneys General Poised to Crack Down On Price Gouging Amid Market Pressure

This past Thursday, New York Attorney General Letitia James issued a warning to businesses against price gouging for eggs and poultry. The current bird flu outbreak began in March 2024 but has become a topic of increasing concern for consumers and businesses in the new year after more than 13 million hens—necessary to the success… Continue Reading
Compliance

AI Risk and Whistleblower Protection Spotlighted in DOJ’s Revised Corporate Compliance Guidance

On September 23, 2024, the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs (ECCP) guidance. The ECCP provides prosecutors with questions and factors to consider when assessing a company’s compliance program. Prosecutors use the guidance to assist in making decisions about whether to charge a company and how to resolve cases. The… Continue Reading
Compliance

“Call Us Before We Call You”:  DOJ’s New Corporate Whistleblower Awards Pilot Program

On September 17, 2024, Deputy Assistant Attorney General Nicole Argentieri stressed the intense focus placed by the U.S. Department of Justice (DOJ or the Department) on incentivizing companies to maintain healthy corporate compliance programs – and highlighted key aspects of the Department’s newest enforcement tool.  Speaking at the NYU School of Law’s Program on Corporate… Continue Reading
Compliance, Fraud, Deception and False Claims

Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare

McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky recently conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (PE) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space. Read on to learn about the eight key… Continue Reading
Compliance, Financial Institution Regulation, Securities and Commodities

Spring Has Sprung for Recent Reg NMS Reporting Changes

On March 6, the SEC released its long-anticipated adopting release amending Rule 605.[1]  Separately, in late February, FINRA issued Regulatory Notice 24-05 discussing new FINRA Rule 6151, which requires member firms to provide Rule 606 reports to FINRA. The following provides a brief overview of these recent moves by both regulators.   … Continue Reading
Anti-Money Laundering, Compliance

Federal District Court Declares Corporate Transparency Act (CTA) Unconstitutional

On March 1, 2024, the United States District Court for the Northern District of Alabama declared the Corporate Transparency Act (“CTA”) unconstitutional.  Enacted as part of the Anti-Money Laundering Act of 2020, the CTA requires certain legal entities to report beneficial ownership information (“BOI”) to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”). … Continue Reading
Compliance

FinCEN Issues Access Rule Compliance Guide for Beneficial Ownership Information

Rule Regarding Access to Beneficial Ownership Information Takes Effect On February 21, 2024, FinCEN published a Small Entity Compliance Guide to aid in compliance with the Corporate Transparency Act’s (“CTA”) Beneficial Ownership Information (“BOI”) Access and Safeguards Rule (“Access Rule”).  The Compliance Guide is called the Small Entity Compliance Guide only because federal law requires… Continue Reading
Anti-Money Laundering, Compliance

FinCEN Extends Time to File Beneficial Ownership Information for Entities Created After January 1, 2024

The Corporate Transparency Act (“CTA”) was enacted in 2021 as part of the Anti-Money Laundering Act of 2020. The CTA requires certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”), and, for entities created or registered on or after January 1, 2024, information with respect to any individual who directly files the document… Continue Reading
Anti-Money Laundering, Compliance

FinCEN Specifies When and How Reporting Companies May Use FinCEN Identifiers

The Corporate Transparency Act (“CTA”) was enacted in 2021 as part of the Anti-Money Laundering Act of 2020, requiring certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”), and, for entities created or registered on or after January 1, 2024, information with respect to any individual who directly files the document creating the… Continue Reading
Anti-Money Laundering, Compliance

Beneficial Ownership Reporting Requirements under the Corporate Transparency Act

Corporate Transparency Act Beneficial Ownership Reporting Requirements to Take Effect In 2021, the Corporate Transparency Act (“CTA”) was enacted as part of the Anti-Money Laundering Act of 2020, requiring certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”) to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”).  FinCEN issued the final… Continue Reading
Compliance, Enforcement and Prosecution Policy and Trends

DOJ Announces Safe Harbor Policy for Mergers and Acquisitions

In the U.S. Department of Justice’s continuing efforts to incentivize voluntary disclosure of corporate misconduct, Deputy Attorney General Lisa Monaco announced the Criminal Division’s latest corporate self-disclosure policy this week, aimed at mergers and acquisitions specifically (remarks Here).  Pursuant to DOJ’s new Mergers and Acquisitions Safe Harbor Policy (the “Policy”), acquiring companies that promptly and… Continue Reading
Compliance

California Climate Accountability Package Poised to Disrupt

During the week of September 11, 2023, the California Legislature passed a series of bills known collectively as the “California Climate Accountability Package” (“CCAP”).  The CCAP is comprised of three bills: S.B. 252 (applicable only to two California state pension funds, and not discussed further herein), S.B. 253 (the “Climate Corporate Data Accountability Act” of… Continue Reading
Compliance

“There are Cops on the Beat”: DOJ’s Procurement Collusion Strike Force Leader Emphasizes Criminal Antitrust as Top Enforcement Priority

On September 14, 2023, Daniel W. Glad — Director of the Procurement Collusion Strike Force (“Strike Force”) for the Department of Justice’s (“DOJ”) Antitrust Division — gave remarks as the keynote speaker for the Virginia Bar Association’s Annual White-Collar Fall Forum, emphasizing a renewed commitment to pursuing criminal investigations in the federal procurement arena.  DOJ… Continue Reading
Compliance, Enforcement and Prosecution Policy and Trends

U.S. Attorneys’ Offices Adopt Policy Incentivizing Self-Disclosure of Corporate Misconduct

On Feb. 22, 2023, U.S. Attorneys’ Offices throughout the country adopted a new policy that incentivizes corporate voluntary self-disclosure of misconduct.  Deputy Attorney General Lisa Monaco’s Sept. 15, 2022 memorandum (“Monaco Memo”) instructed all DOJ sections to review their policies incentivizing corporate voluntary self-disclosure or, if no formal written policy existed, to draft and publish… Continue Reading
Compliance, Securities and Commodities

SEC Issues Risk Alert on Reg BI Deficiencies Identified During Exams

On Jan. 30, the U.S. Securities and Exchange Commission’s Division of Examinations released a Risk Alert identifying perceived weaknesses in broker-dealers’ compliance with the disclosure, care, conflicts of interest and compliance obligations of Regulation Best Interest. Read on for highlights from the alert and how they reflect the SEC’s evolving expectations during examinations… Continue Reading
Compliance

Department of Justice Criminal Chief Points to Prevention as Key Aspect of Corporate Compliance

The Assistant Attorney General and head of the Department of Justice’s Criminal Division recently sat for an interview with the Wall Street Journal where he provided important insight into the Department’s increased focus on corporate compliance. Drawing on his experience in the U.S. Attorney’s office and as the Chief Compliance Officer at a Fortune 500… Continue Reading
Compliance, Enforcement and Prosecution Policy and Trends, Government Contracts

Webinar: OSHA ETS Employee COVID-19 Vaccination and Testing Mandates

New Requirements, Tips and Traps for Large Employers November 10, 2021 Complimentary Webinar 1-2 p.m. (ET) | 12-1 p.m. (CT) | 10-11 a.m. (PT) REGISTER NOW On Nov. 4, 2021, the Occupational Safety and Health Administration (OSHA) issued an Emergency Temporary Standard (ETS) requiring employees of large employers either to get vaccinated or to test negative… Continue Reading
Compliance

Gleanings From DOJ’s 2021 Healthcare Takedown Announcement

On Sept. 17, the U.S. Department of Justice released the results of its 2021 Healthcare Takedown — an annual announcement aggregating months of investigations and indictments across the country involving fraud in the healthcare and life sciences industries. Read on for details and analysis of criminal charges against 138 defendants, including 42 medical professionals, related… Continue Reading
Compliance

DOJ Title IX Investigation Leads to $1.6M Agreement with San Jose State University

The Department of Justice’s Civil Rights Division, the U.S. Attorney’s Office for the Northern District of California, and San Jose State University (SJSU) settled the government’s Title IX investigation into a decade’s worth of sexual harassment allegations. The June 2020 allegations of “employee-on-student sexual harassment” and retaliation within SJSU’s athletics department prompted the government’s investigation.… Continue Reading

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