The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally Published in… more

Vision 2050 - As one of the fastest growing regions in the United States, Orange County has been working to amend their state-required Comprehensive Plan called, “Vision 2050.” Vision 2050 is drafted with two of Orange County’s key… more

In the latest chapter of a long-running investigation by the U.S. Department of Justice (DOJ) Antitrust Division into real estate industry practices, the D.C. Circuit revived DOJ’s 2021 investigation of the National Association of… more

Title? Typo? Cryptic code? Equation? Really it is a combination of three of the four. In other words, it is not a typo (You can look elsewhere in this piece for those)… more

The Fluid Mineral Leases and Leasing Process rule (FMLLP), which was announced by the Bureau of Land Management (BLM) on April 12, 2024, represents a significant update to the Federal onshore oil and gas leasing framework. The FMLLP is… more

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our attorneys… more

The big regulatory news out of the FTC in April was the issuance of a new Final Rule governing noncompete agreements. If it becomes effective, the new rule, which would ban most noncompetes nationwide, would radically change the… more

On April 17, 2024, the Supreme Court issued a decision in Muldrow vs. City of St. Louis, which held that Title VII – which bars employers from discriminating in decisions involving among other things, lateral transfers – does not… more

The general public's enthusiasm for artificial intelligence (AI) technologies is making its way into the workplace. While AI offers many advantages, employers must remain aware of the risks that a lack of supervision can… more

On April 30, 2024, the Department of State proposed an amendment to the International Traffic in Arms Regulations (ITAR) intended to facilitate exports of defense articles, the performance of defense services, and brokering activities… more

In our latest roundup, nonresidential construction increases, Redfin settles lawsuits, overseas real estate becomes more lucrative than domestic real estate, and more!… more

Jorge Martinez v. Lewis Tree Service (Workers’ Compensation Appeal Board); No. 298 C.D. 2023; filed Feb. 8, 2024; Senior Judge Leavitt - The claimant worked as a crew leader for the employer’s tree-trimming business. On October 1… more

On April 9, 2024, the US Department of the Treasury and the Internal Revenue Service issued long-awaited proposed regulations under Section 4501 of the Internal Revenue Code (the “Code”) regarding the 1% stock buyback excise tax (the… more

Welcome to Compliance Notes from Nossaman’s Government Relations & Regulation Group – a periodic digest of the headlines, statutory and regulatory changes and court cases involving campaign finance, lobbying compliance, election law… more

Probate litigation can be a complicated and emotionally taxing process, especially in a state like New York known for its stringent probate laws. When disputes arise over the distribution of assets or the validity of a will, navigating… more

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v. The… more

As threatened, TikTok, Inc. and ByteDance, Ltd., the owner of the TikTok app, filed suit against the United States on May 7, 2024, alleging that the Protecting Americans From Foreign Adversary Controlled Applications Act (“the Act”) is… more

On 1 May 2024, the US State Department’s Directorate of Defense Trade Controls (DDTC) issued a proposed rule to amend the International Traffic in Arms Regulations (ITAR) to support the goals of the trilateral security partnership… more

Effective October 1, 2024, Maryland will become the sixth state (plus the District of Columbia), to require that employers provide an upfront disclosure of the wage or salary range for open positions in job listings. The new law… more

Defendants often face a tough choice — challenge the government’s evidence and if convicted, face significant jail time.  On the flip side, defendants who plead guilty and cooperate can earn significant sentencing reductions, even… more

Congress is once again entertaining federal privacy legislation. The American Privacy Rights Act (APRA) was introduced by Senate Commerce Committee Chair Maria Cantwell (D-WA) and House Energy and Commerce Chair Cathy McMorris Rodgers… more

Boeing is not the first company to find itself amid a massive scandal. You can think of Siemens’ bribery and corruption scandal, the VW emissions-testing scandal, the Wells Fargo fraudulent accounts scandal, or any other myriad of… more

On May 9, 2024, the Dufresne Spencer Group, LLC (“DSG”) filed a notice of data breach with the Attorney General of Texas after discovering that an unauthorized party was able to access the company’s IT network. In this notice, the… more

On May 1, 2024, the Council on Environmental Quality (CEQ) published its final Bipartisan Permitting Reform Implementation Rule (Final Rule), that revises regulations implementing the National Environmental Policy Act (NEPA), in part… more

On Friday,19 April 2024, the US Environmental Protection Agency (EPA) issued a final rule to designate two common per-and polyfluoroalkyl (PFAS) chemicals, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as… more

Big news dropped in the past few weeks, which sent shockwaves across the industry: according to a recently filed lawsuit, the SEC has classified the second largest cryptocurrency, Ether, as a security in certain ongoing investigations… more

The Buy American Act was originally passed by Congress in 1933 and has undergone numerous changes across several presidential administrations. While the core of the Act has essentially remained the same, requiring the U.S. government… more

Labor Law Insider host Tom Godar challenges his guests, Mary-Ann Czak and Terry Potter, with real-life scenarios gathered from client interactions over the past several months. These scenarios help highlight the fundamental shifts that… more

DSOs have been recognizing the strong demand for pediatric dental services, driven by factors such as a growing population of children and expansions in state reimbursement programs. Other factors that are influencing a greater push to… more

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector… more

On 10 April 2024, the FCA published its consultation paper (CP24/7) on payment optionality for investment research. This followed the Investment Research Review’s report from summer 2023, which recommended that the FCA should permit… more

The IRS recently issued private letter ruling (PLR) 107770-22 that involved a normalization issue of first impression, namely, whether payments received by a utility pursuant to an intercompany tax allocation agreement (TAA) can reduce… more

With the rising use of artificial intelligence-written text, demand for ways to identify whether content is human-written or AI-generated is likewise increasing. One such tool embeds patterns of words interwoven into AI-generated text… more

DOJ DOUBLES DOWN ON CORPORATE ENFORCEMENT WITH NEW WHISTLEBLOWER PROGRAM - During the 2024 American Bar Association National Institute on White Collar Crime (the 2024 White Collar Conference) earlier in March US Attorney General… more

On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program… more

You are reading the April 2024 Update of the Bass, Berry & Sims Enforcement Roundup, where we bring notable enforcement actions, policy changes, interesting news articles, and a bit of our insight to your inbox. April saw continuing… more

The Federal Circuit considered the relevance of an alleged infringer’s intent in a safe harbor analysis in Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. The District Court had previously granted summary judgment that Meril’s… more

Coming off the heels of the $100 million Sprint for Women’s Health, menopause care and treatment grabbed the spotlight on Capitol Hill on May 2, 2024… more

In today’s data-driven world, law firms rely on large amounts of data to develop relationships, win new business, and serve client needs. Whether attorneys or professionals are managing client relationships in their CRM or leveraging… more

In Patterson v. United Healthcare Insurance Company, 76 F.4th 487 (6th Cir. 2023), the Sixth Circuit held that the plaintiff insured had stated an equitable claim for disgorgement under ERISA where he sought disgorgement of money he… more

According to the California Department of Aging, more than 200,000 older and dependent adult abuse cases are reported each year. Many more cases certainly go unreported… more

Bradley has been publishing an ongoing survey of state-level bid protest processes and procedures (e.g., our posts on “Bid Protests in North Carolina,” “Bid Protests in Georgia,” “Bid Protests in the District of Columbia,” “Bid… more

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization (“Requestor”)… more

The line between virtual and reality is getting thinner. Gamers pay gaming companies real currency for virtual in-game currency to buy skins, create the world they want to live in (virtually), or purchase loot that aid in their game… more

Our notable ruling roundup aims to keep our readers up to date on recent rulings in the food & consumer packaged goods space… more

In late April, Colorado took a major step toward adding further complexity to the already fragmented U.S. biometrics legal landscape with the passage of HB 1130. The bill, which amends the Colorado Privacy Act (CPA), is likely to be… more

Intended to help expedite transmission siting to facilitate achievement of the State’s Climate Leadership and Community Protection Act (“CLCPA”) goals, the RAPID Act makes several significant structural changes to New York’s major… more

On April 15, 2024, the Department of Justice released its “Criminal Division’s Pilot Program on Voluntary Self-Disclosures for Individuals.” Similar in many ways to programs introduced earlier this year by the U.S. Attorney’s Offices… more

Addressing the issue of whether to discretionally deny a petition for inter partes review (IPR) under the General Plastics factors when there is no “significant relationship” between the petitioners, the Director of the US Patent &… more

Welcome to the Regulatory Roundup. Each month, Eversheds Sutherland Investment Services attorneys review significant regulatory developments (including notable rulemakings and guidance from securities regulators) from the previous… more

On May 9, 2024, the IRS announced the Health Savings Account limits for 2025.  With respect to contribution limits, the limits are higher than the ones for 2024 and the required deductible and out-of-pocket maximums have increased as… more

The Question - The basics of California’s wage statement requirements should be familiar to employers. The consequences for failing to comply with these requirements can be severe… more

The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason Reddish… more

Issuing a revised opinion following the Supreme Court’s 2023 decision in Abitron Austria GmbH v. Hetronic Int’l, Inc., the US Court of Appeals for the Tenth Circuit determined that none of the defendant’s purely foreign sales to… more

On May 2, the Department of Defense (DOD) issued a class deviation to DFARS 252.204-7012 “to provide industry time for a more deliberate transition upon the forthcoming release of [National Institute of Standards and Technology (NIST)… more

The Financial Industries Regulatory Authority (FINRA) has created a parallel universe for handling disputes outside of the regular court system. It’s a bit like a sci-fi heroine finding herself in an alternate universe where up is down… more

The human element in your supply chain - There is little risk in claiming that ESG (Environment, Social, Governance) has been one of the most used acronyms over the last few years. Some salient examples that changed how businesses… more

If an employer or coworker persistently uses a transgender worker’s wrong name or identified pronoun, can that constitute a hostile work environment in violation of Title VII? In Copeland v. Georgia Department of Corrections, the… more