FDA Issues Draft Guidance to Accelerate Development of Medical Devices to Combat Opioid Crisis

The U.S. Food and Drug Administration (FDA) continues to take proactive steps in the battle against opioid misuse. The FDA has recently made public draft guidance regarding the study and testing of medical devices for treating opioid use disorder (OUD), as noted by Knobbe Martens. These newly-proposed guidelines align with the FDA’s established Overdose Prevention…

Read More

FAA Shifts Stance on States’ Role in Drone Regulation: Implications for Operators and Jurisdictions

In a recent development, the Federal Aviation Administration (“FAA”) released an updated Fact Sheet elucidating its viewpoint on the powers of state and local governments when it comes to regulating drone activities. This revised stance marks a crucial change in the role that different levels of governments play in drone regulation, addressing particularly the FAA’s…

Read More

Connecticut Comptroller Surveys Municipal Retirement Plans in Compliance with Public Act 23-182

In compliance with Connecticut Public Act 23-182, the Connecticut Comptroller’s Office has initiated a survey to collect information on retirement plans from municipalities across the state. The Act necessitates municipalities sponsoring these retirement plans to submit relevant data and documents to the Comptroller’s Office by September 1, 2023. As reported by Pullman & Comley, LLC,…

Read More

Third Circuit Court Allows Creditors to Claim Venezuelan Oil Company’s U.S. Assets

In a noteworthy decision, the Third Circuit Court of Appeals has reiterated its prior judgment allowing creditors of Venezuela who have obtained arbitration awards to lay claim on the U.S. assets of Petroleos De Venezuela, S.A. (PDVSA), Venezuela’s national oil company. This conclusion, accessible in detail via the following link, Third Circuit Affirms Judgment Allowing…

Read More

FedNow Launches Instant Payments Service, Balancing Fintech Advancements and Regulatory Measures

In an era rapidly marked by fintech evolution and regulatory hurdles, the U.S. Central Bank, the Federal Reserve has launched the FedNow® Instant Payments Service, its new instant payment solution. Revealed in a recent press release, this new payment system is accessible for financial institutions of all sizes, offering the ability to instantly process transactions…

Read More

Senate Introduces False Claims Amendments Act of 2023: Potential Implications for Whistleblowing and Liability

On July 25, 2023, Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), John Kennedy (R-LA), and Roger Wicker (R-MS) introduced the False Claims Amendments Act of 2023. This development was reported by the reputable law firm, Arnall Golden Gregory LLP. The proposed amendment to the False Claims Act does not eliminate the requirement that the alleged…

Read More

US Government’s Tri-Seal Compliance Note Clarifies Framework for Corporate Voluntary Self-Disclosure

On July 26, 2023, the U.S. Department of Justice’s (DOJ) National Security Division, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS), and the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued a Tri-Seal Compliance Note regarding the self-disclosure of potential violations of U.S. sanctions and export controls, as…

Read More

Texas Court Halts CFPB Rule on Lending Data Collection for Women-Owned, Minority-Owned, and Small Businesses

On Monday, the contentious issue regarding the implementation and enforcement of the Consumer Financial Protection Bureau’s (CFPB) final rule gained a preliminary injunction issued by a Texas federal district court, according to this article. The lawsuit challenging the validity of the Rule was based on Section 1071 of the Dodd-Frank Act. Nevertheless, this injunction was…

Read More

UK Property Developers Face Strict Enforcement with Building Safety Act Responsible Actors Scheme

Swift action is the watchword for residential property developers in the UK as the Building Safety Act Responsible Actors Scheme (“RAS”) commences enforcement. Provisions of the Responsible Actors Scheme, which came into effect on 23 July 2023, mandate remediation of fire safety defects in relevant buildings by developers, failure of which could result in them…

Read More

Court Dismisses NGO Effort to Rescind Oil Project Approval, Signaling Climate Impact Challenges

The Federal Court has recently delivered a verdict dismissing an effort by non-governmental organizations (NGOs) to rescind ministerial approval of a notable offshore oil and gas project. The NGOs claimed that the approving minister did not consider downstream emissions and marine shipping hazards in the approval process. This highlighted case suggests NGOs’ increasing utilization of…

Read More

Navigating Compliance in the Era of Diverse Business Communication Platforms

In today’s digital age, email no longer holds a monopoly on business communications. Workers across the globe are increasingly leveraging devices and applications such as texts, WhatsApp, Slack, Teams, and countless other tools to communicate with coworkers, clients, and prospects. This shift has certainly expedited communication and improved the fluidity of team collaborations, but it…

Read More

TSA’s Enhanced Pipeline Security Directive: Bolstering Infrastructure Resilience Against Cyber Threats

In response to recent technological threats, such as the Colonial Pipeline ransomware attack, The Department of Homeland Security’s Transportation Security Administration (TSA) has issued a revised directive addressing pipeline security, named SD-Pipeline-2021-02D (the Directive). The newly introduced directive replaces its predecessor, SD-Pipeline-2021-02C, adding to the growing series of amendments in this sphere. These changes introduced…

Read More

Hiring with Compliance in Mind: The Skill, Will, and Fit Approach for Global Businesses

When it comes to hiring, the importance of considering compliance cannot be overemphasized, especially in the context of family members of foreign government officials or employees of state-owned enterprises. This is the subject of an interesting exploration recently discussed by Tom Fox, a seasoned Compliance Evangelist, in a podcast episode. In the podcast, Fox highlights…

Read More

Canada’s Chemical Risk Assessment: Government Requests Data on 850 Substances for Environmental Protection

Canada has taken a significant step towards mitigating environmental risks associated with certain chemical substances. As reported by JDSupra, the Canadian government announced through a notice in the Canada Gazette on June 24, 2023, that it’s requesting information about approximately 850 different chemical substances. This information is being gathered with the primary objectives of prioritisation,…

Read More

Biden Administration’s Push for Enhanced Mental Health Coverage Compliance: Implications for Corporations and Law Firms

The Biden administration recently made known its intention to enhance accessibility to mental health coverage through a proposed rule primarily involving the expansion of plan oversight and enforcement activity. Spearheading this initiative are the US Departments of the Treasury, Labor, and Health and Human Services. This move aims to address the issues concerning mental health…

Read More

Revised Form I-9 Requirements and Remote Worker Compliance Rules for Employers by November 2023

The U.S. Citizenship and Immigration Service (USCIS) has recently conveyed that employers are required to use a revised Form I-9 by November 1, 2023. A fresh rule authorising employers to utilise an alternative documentation verification system for employees operating remotely is also introduced by USCIS. The alterations indicate significant changes for businesses across the nation,…

Read More

Transforming for Tomorrow: NILG 2023 National Conference Kicks Off in Phoenix

Day one of the National Industry Liaison Group (NILG) 2023 National Conference commenced in Phoenix, Arizona, witnessing a full attendance despite soaring temperatures. Attendees comprising conference presenters, vendors, and agency representatives were treated to diverse and informative sessions that aligned seamlessly with this year’s proactive conference theme of “Transforming for Tomorrow”. The first day of…

Read More

Strengthening Fair Market Value Defensibility in Healthcare Compensation Agreements

As legal practitioners in the global business arena, the analysis of Fair Market Value (FMV) is often an area demanding utmost attention and precision. FMV, predominantly an issue of significance in regulatory compliance and compensation agreements concerning the healthcare sector, prompts a meticulous investigation of its defensibility. The following discussion draws on Health Care Compliance…

Read More