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Compliance Regulatory Oversight Enforcement Actions

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Thomas Fox - Compliance Evangelist

2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition

What happens when two top compliance commentators get together? They talk compliance, of course. Join Tom Fox and Kristy Grant-Hart in 2 Gurus Talk Compliance as they discuss the latest compliance issues in this week’s...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Ropes & Gray LLP

Five Takeaways From the EU Commission’s AI Literacy Q&As

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Earlier this month, the European Commission released AI Literacy – Questions & Answers. The Q&As are a useful primer — both for organisations at the start of their literacy journey and those that, having taken steps to...more

Lippes Mathias LLP

The Future of Monitorships

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In 2008, then-President Barack Obama famously said, “Elections have consequences.” Seventeen years later that statement is still true. A change in administration at either the federal or state government level ushers in new...more

Mayer Brown

New Federal Decree Regulates Renovabio Penalties

Mayer Brown on

On April 17, Federal Decree No. 12,437/2025 (the “Decree”) was published, regulating recent amendments to the National Biofuels Policy (Renovabio) introduced by Law No. 15,082/2024. The Decree aims to strengthen oversight...more

Davis Wright Tremaine LLP

CFTC Divisions Issue Staff Advisory on Referrals to Division of Enforcement

On April 17, 2025, the Market Participants Division, the Division of Clearing and Risk, and the Division of Market Oversight (collectively, the "Operating Divisions") of the CFTC, along with the Division of Enforcement...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

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In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Cadwalader, Wickersham & Taft LLP

Regulation in Flux, March 2025 - CFTC Staff Withdraws Advisory on Swap Execution Facility Registration Requirement

On March 13, 2025, the Commodities Futures Trading Commission (“CFTC”) issued Letter 25-05, withdrawing controversial and much-criticized Staff Letter 21-19 (“SEF Registration Advisory”), which was issued September 29, 2021...more

Seward & Kissel LLP

CFTC’s Spring Cleaning: Let's Make a Deal (Quickly)

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The Commodity Futures Trading Commission (CFTC) has a lot on its plate—too many enforcement cases, not enough time, and a limited appetite for dragging out every compliance misstep. So, yesterday, at the International Futures...more

Cadwalader, Wickersham & Taft LLP

Amid Chaos, Regulatory Change Continues Apace, March 2025 - New CFTC Enforcement Guidance

On February 25th, 2025, the Commodity Futures Trading Commission’s (“CFTC”) Division of Enforcement (“Division”) issued a long-awaited advisory (the “Advisory”) regarding its evaluation of how a company’s or individual’s...more

McDermott Will & Emery

SEC Pumps Fun

While we anticipated a relaxed US Securities and Exchange Commission (SEC) under the new administration, even the biggest proponents of a lax SEC did not expect a “meme coin” blessing within weeks of a new SEC chair being...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Will the CFTC’s New Top Cop Usher in an Era of Increased Investigation and Related Rewards for Whistleblowers?

On February 14, 2025, the Commodity Futures Trading Commission (CFTC) signaled some “love” for whistleblowers and the future of the CFTC’s whistleblower program when announcing that Brian Young had been appointed as a new...more

Skadden, Arps, Slate, Meagher & Flom LLP

Annual Report Highlights France’s Financial Crime Enforcement and International Cooperation

Ten years after its establishment, France’s National Financial Prosecutor’s Office (Parquet National Financier or PNF) has released its 2024 annual report (Report),1 showcasing a year of consolidation and innovation in the...more

Orrick, Herrington & Sutcliffe LLP

CFPB obtains fortnight extension to inform the court of its intent to pursue action

On February 12, the U.S. SDNY granted the CFPB’s request to extend its deadline to explain if the Bureau wishes to continue its litigation efforts. The Bureau filed a letter with the SDNY requesting a two-week extension. The...more

A&O Shearman

UK Payment Systems Regulator publishes compliance monitoring framework

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The Payment Systems Regulator (PSR) has published a policy statement (PS25/2) on its new compliance monitoring framework, setting out the scope of its monitoring work, its approach to compliance monitoring and how, in...more

DLA Piper

President Trump’s Executive Order Pauses FCPA Enforcement Pending Attorney General Review

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On February 10, 2025, President Donald Trump signed an Executive Order (EO) directing Attorney General (AG) Pam Bondi to pause enforcement of the Foreign Corrupt Practices Act (FCPA) until new enforcement guidelines and...more

A&O Shearman

New U.K. regulatory landscape: enforcement and supervision shift

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This article examines the latest trends in U.K. regulatory enforcement and supervisory action and highlights the key takeaways for firms in 2025 and beyond. Over the past 18 months, the Financial Conduct Authority (FCA)...more

Paul Hastings LLP

SEC Reportedly Requiring Enforcement Staff to Seek Commission Approval for Formal Orders of Investigation

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On February 2, media outlets reported that the Securities and Exchange Commission (SEC or Commission) has told SEC Enforcement attorneys that they need the approval of the agency’s commissioners for all formal orders of...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Cozen O'Connor

Sports Betting Companies Pay $6.5 Million for Allegedly Conspiring to Violate D.C. Laws

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District of Columbia AG Brian Schwalb has settled with Intralot, Inc. and Veterans Services Corporation (VSC) to resolve an investigation into allegations that the companies deceived city officials in violation of the...more

Akin Gump Strauss Hauer & Feld LLP

FERC Proposes Landmark Penalty for Alleged Energy Efficiency Resource Capacity Market Manipulation

On December 16, 2024, the Federal Energy Regulatory Commission (FERC or the Commission) issued an Order to Show Cause and Notice of Proposed Penalty proposing to assess staggering civil penalties against American Efficient,...more

Robinson+Cole Data Privacy + Security Insider

A Year in Privacy and Security: Privacy Violations, Large-Scale Data Breaches, and Big Fines and Settlements

2024 was a year chock-full of data breaches and privacy violations. Many new data privacy and cybersecurity regulations were introduced (and became effective), and regulators sent a strong message to businesses that privacy...more

K&L Gates LLP

2025: Ofcom's Year of Enforcement

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The Online Safety Act 2023 (the Act), aims to protect people online, particularly children, and places more responsibility on online media platforms and search engines, which now have new legal duties to protect users’ safety...more

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