DROPLETS
The D.C. Circuit has reversed longstanding FDA practice on 180-day generic drug exclusivity, holding that a first-filer's failure to obtain timely tentative approval is only excused if an agency delay was the 'but-for' cause.
In a significant ruling for generic drug manufacturers, the D.C. Circuit rejected the FDA's long-standing 'multiple sufficient causes' test for an exception to the forfeiture of 180-day market exclusivity. Previously, the FDA allowed a first Abbreviated New Drug Application (ANDA) filer to retain its valuable exclusivity if a change in approval requirements was merely one of several reasons for failing to obtain tentative approval within the statutory 30-month window.
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The SEC has proposed Regulation Crypto Assets, a new framework creating tailored registration exemptions, disclosure rules, and a transition path for crypto offerings structured as investment contracts.
The U.S. Securities and Exchange Commission has proposed "Regulation Crypto Assets," a landmark rulemaking intended to shift from regulation-by-enforcement to a clear framework for digital asset offerings. The proposal creates two new exemptions from Securities Act registration for crypto assets sold as part of an investment contract: a "Startup Exemption" for offerings up to $5 million and a tiered "Fundraising Exemption," modeled on Regulation A, for raises up to $75 million. For sophisticated counsel, the rule provides the first defined pathways for clients to raise capital in the crypto space while complying with federal securities laws. It also introduces a principles-based disclosure regime tailored to crypto and a novel safe harbor allowing an investment contract to "cease to exist" once the issuer's essential managerial efforts are complete. This provides a potential off-ramp from securities regulation for mature, decentralized projects. Market participants should monitor the 60-day comment period and consider the proposal's interaction with pending federal legislation.
A new executive order invokes national emergency powers to prohibit or condition transactions involving foreign-made electric grid equipment from certain countries, citing national security risks.
The President has issued Executive Order 14420, declaring a national emergency to address foreign threats to the U.S. bulk-power system. Invoking the International Emergency Economic Powers Act (IEEPA), the order creates a new security review process and generally bars the acquisition or installation of bulk-power system equipment from designated 'Covered Foreign Entities'—initially including countries under U.S. sanctions or arms embargoes like China and Russia.
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A new executive order allows the Department of Energy to block power-grid equipment from foreign adversaries like China and Russia, creating immediate supply-chain uncertainty for energy and data-center projects.
A new U.S. executive order declares a national emergency to secure the bulk-power system (BPS), creating significant uncertainty for energy and data-center infrastructure projects. The order invokes the International Emergency Economic Powers Act to authorize the Department of Energy (DOE) to prohibit or impose conditions on transactions involving BPS equipment designed, manufactured, or supplied by entities with ties to designated foreign adversaries, including China and Russia. The rule applies to transactions initiated after August 26, 2026, and its broad scope covers critical hardware like transformers, turbines, inverters, and battery energy storage systems, as well as associated software, firmware, and digital services. Sophisticated counsel should advise clients that the order also empowers the DOE to regulate already-installed equipment, though immediate replacement mandates are not anticipated. Project developers, suppliers, and financiers must now conduct urgent supply-chain diligence and revise contracts to allocate potential costs from procurement delays, equipment substi
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A New York bill introduced after the legislative session would opt the state out of DIDMCA interest-rate preemption for loans to residents, signaling a major 2027 fight for out-of-state banks and their fintech partners.
A New York state senator has introduced legislation that would opt the state out of the Depository Institutions Deregulation and Monetary Control Act of 1980 (DIDMCA). This federal law allows federally insured, state-chartered banks to charge interest at rates permitted by their home state, regardless of the borrower's location. The bill would subject consumer loans "made" in New York to the state's own interest-rate limits, including its 25% criminal usury cap.
This matters because New York is the nation’s fourth-largest state, and its withdrawal from the DIDMCA framework would substantially increase regulatory risk for interstate lending programs, particularly those involving fintech partners. The bill broadly defines a loan as being "made" in New York if the borrower is a resident, a definition that is already the subject of federal litigation concerning opt-out laws in Colorado and Oregon.
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The SEC has advanced its crypto custody rule, the OCC and FDIC have finalized the definition of an 'unsafe or unsound' practice, and the CFTC is moving on swap execution facility rules.
Multiple US financial regulators have advanced significant rulemakings. The SEC submitted proposed amendments to its custody rules to the White House for review, which are intended to modernize the framework for investment advisers, particularly regarding crypto assets. The text is not yet public, but the agency's agenda targets October 2026 for a notice of proposed rulemaking. Separately, the OCC and FDIC issued a joint final rule defining an 'unsafe or unsound practice.' This narrows the grounds on which examiners can issue supervisory warnings, or MRAs, potentially providing more certainty for banks serving digital asset businesses by tying MRAs to practices that could cause material financial harm or violate a law. Concurrently, the CFTC proposed eliminating the order book requirement for certain swap execution facility transactions, while the comment period closed on a joint SEC-CFTC effort to clarify derivatives definitions, drawing comments on whether sports-wagering contracts qualify as swaps.
The Federal Trade Commission has released a proposed enforcement policy statement indicating it will use Section 5 of the FTC Act to target undisclosed or deceptive personalized pricing practices.
The U.S. Federal Trade Commission is targeting personalized and dynamic pricing with a newly proposed enforcement policy statement. The announcement signals the agency's intent to use its authority under Section 5 of the FTC Act, which prohibits unfair or deceptive acts, to scrutinize businesses that use consumer data to set individualized prices. The policy, which is not a formal rule or ban, focuses on transparency and fairness. It posits that failing to clearly disclose that prices are personalized, the basis for the personalization, and the types of data used may be an unfair or deceptive practice. The FTC also highlighted concerns about deceptive framing, such as presenting a higher price as a special discount, and unfairness that occurs when concealment prevents consumers from avoiding harm. The proposal provides several examples of potentially unlawful conduct, including a delivery service charging higher prices to consumers whose data suggests they are homebound. The agency is seeking public comment on the proposal.
The CFTC chairman has directed staff to explore creating a market structure for digital assets under the agency's current powers, citing stalled legislation.
In a significant policy signal, CFTC Chairman Michael Selig has directed agency staff to explore using existing authority to establish a market structure for crypto assets. The move comes amid concerns that the CLARITY Act, a bipartisan legislative effort to regulate digital assets, may not pass Congress in a timely manner. This directive could bypass the legislative stalemate and create a regulatory framework for digital asset markets directly through the CFTC's rulemaking process. For financial institutions and crypto-native firms, this development presents both opportunities and challenges. A formal CFTC-regulated market could provide much-needed legal clarity, potentially allowing crypto exchanges to register as a new type of designated contract market (DCM) for leveraged trading. However, it would also introduce new compliance and oversight burdens. Legal and compliance teams should closely monitor the CFTC for any forthcoming proposed rules and prepare to engage with the rulemaking process, as the outcome could reshape US digital asset trading and DeFi protocol operations.
A Fourth Circuit panel invalidated the FCC's lowest unit charge guidance for political ads and held that the agency cannot shield bureau-level decisions from judicial review.
The U.S. Court of Appeals for the Fourth Circuit has invalidated Federal Communications Commission guidance on calculating the "lowest unit charge" for political advertisements, a key rule for broadcasters. More broadly, the court rejected the FCC's position that decisions issued by its bureaus, rather than the full commission, are not "final agency actions" and are therefore shielded from immediate judicial review.
The ruling has significant consequences for sophisticated counsel and their clients. For media and broadcast companies, it creates immediate uncertainty around the rules for political ad sales, a critical revenue source, especially in an election year. For practitioners across all regulated industries, the decision strengthens their ability to challenge guidance and enforcement advisories issued by agency staff and sub-units without waiting for a formal enforcement action. This holding potentially opens the door to more preemptive litigation against what many regulated entities view as "rulemaking by other means." Counsel should monitor whether the FCC seeks rehearing or
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A new executive order declares a national emergency and directs the Department of Energy to create rules restricting the acquisition and use of bulk-power system electric equipment from designated foreign adversaries.
A new executive order declares a national emergency to address security threats to the U.S. bulk-power system from foreign adversaries. The order prohibits, subject to future regulation, the acquisition, importation, or installation of specified electric-grid equipment manufactured or supplied by persons controlled by or subject to the jurisdiction of a "Covered Foreign Entity." While not self-executing, it directs the Department of Energy to publish implementing rules within 120 days. This action signals a major U.S. policy shift to secure critical infrastructure supply chains. Energy companies, equipment suppliers, and data center operators must now assess their reliance on foreign-produced components, which could range from large transformers to industrial control systems. The order also directs federal procurement agencies to prioritize U.S.-manufactured energy infrastructure. Counsel should monitor the upcoming DoE rulemaking, which will establish licensing and mitigation procedures, and could compel the replacement of currently installed equipment.
The Colorado Attorney General alleges a California-based earned wage access provider is operating an unlicensed, high-cost lending program in violation of state consumer credit and protection laws.
Colorado's Attorney General and its top consumer credit regulator have sued a California-based financial technology company, alleging its earned wage access (EWA) product is a disguised high-cost loan that violates state law. The complaint, filed in state court, argues that the product functions as a loan because consumers must pre-authorize debits, cannot easily revoke that authorization, and are encouraged to pay "tips" that act as undisclosed finance charges.
The lawsuit is a major development in the burgeoning EWA market, which often operates in a gray area of state lending laws. For fintech firms, their financial institution partners, and employers offering these products, this action highlights significant regulatory risk. A ruling that EWA products are loans subject to state licensing, disclosure, and usury laws could reshape the industry's business model. Counsel should monitor this case for its potential to set a precedent in Colorado and to inspire similar enforcement actions by other state regulators examining the EWA space.
The SEC has consolidated nationwide accounting and reporting expertise into a new Enforcement Division unit, signaling an expected uptick in financial-reporting cases against public companies and their auditors.
On August 5, 2026, the SEC announced formation of a dedicated Financial Reporting and Accounting Unit within its Division of Enforcement. The new unit merges resources previously dispersed across headquarters and regional offices, concentrating subject-matter expertise on public-company accounting, financial reporting, disclosures, internal controls, and auditor-engagement failures. Enforcement Director David Woodcock has identified financial-reporting matters as a priority, and Chairman Paul Atkins has framed the move as consistent with refocusing SEC enforcement on its core mission. The unit's scope is expected to reach beyond traditional accounting fraud into non-GAAP measures, revenue recognition, channel stuffing, inventory management, and disclosure controls, with heightened scrutiny of audit firms and executive certifications. Counsel advising boards, audit committees, and disclosure committees should expect increased investigative activity and should review internal controls, materiality analyses under SAB 99, risk-factor and MD&A disclosures, and whistleblower procedures, wh
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A guide from Jackson Lewis details critical AI-specific contract terms to manage risk in technology procurement, including disclosure obligations, data use limitations, and liability.
This podcast transcript offers a guide for counsel on navigating the contractual risks of procuring AI technologies or services that use AI. Attorneys highlight the need to update standard agreements to address AI-specific issues, moving beyond traditional software contracts. Key negotiation points include forcing vendor disclosure of AI use, precisely defining "services" to cover AI-driven activities, and scrutinizing data-use clauses, particularly where vendors want to use client data for model training.
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Private equity giant KKR will acquire medical device manufacturer Integer Holdings Corp. in a going-private transaction valued at approximately $5.7 billion.
Global investment firm KKR has entered into a definitive agreement to acquire Integer Holdings Corp., a publicly traded medical device contract manufacturer, for approximately $5.7 billion. The all-cash transaction will result in Integer becoming a privately held company. Integer, whose brands include Greatbatch Medical and Lake Region Medical, specializes in the cardio and vascular, neuromodulation, and cardiac rhythm management markets.
For sophisticated counsel and their clients, this deal underscores the continued strength and appetite of private equity for large-scale acquisitions in the healthcare and life sciences sectors. The significant valuation serves as a key market indicator for other companies in the medtech space and highlights the viability of take-private transactions as an exit strategy. This move signals a robust pipeline for transactional practices and may prompt other PE firms and strategic acquirers to evaluate similar targets. The transaction is expected to close by the end of the year, subject to customary closing conditions.
The U.S. Treasury's financial-crimes unit has issued new guidance and sanctions targeting a cross-border fuel smuggling and money laundering scheme operated by Mexican cartels.
On June 30, 2026, the Treasury's Financial Crimes Enforcement Network (FinCEN) issued an alert detailing a scheme by Mexican cartels to smuggle U.S.-sourced fuel into Mexico to evade import taxes. The scheme relies on U.S. financial institutions to process payments—including wire transfers and stablecoins—and launder the proceeds. In a parallel action, the Office of Foreign Assets Control (OFAC) sanctioned two individuals and nine entities for their roles in the operation.
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Policymakers are considering designating certain drug cartels as Foreign Terrorist Organizations and using FinCEN special measures, a move with profound compliance implications for US businesses.
A recent analysis highlights a growing policy debate in Washington over treating certain transnational drug cartels as national security threats, rather than purely criminal enterprises. Proponents of this shift advocate for deploying potent legal tools, including designating cartels as Foreign Terrorist Organizations (FTOs) and subjecting them to 'special measures' by the Financial Crimes Enforcement Network (FinCEN) under Section 311 of the USA PATRIOT Act.
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New proposed regulations establish the framework for employer contributions to 'Trump Accounts,' including plan document, nondiscrimination, and investment-limitation rules.
The U.S. Treasury and IRS have released proposed regulations detailing the operational framework for "Trump Accounts," a new type of tax-advantaged savings vehicle for children. The guidance is critical for employers, as it outlines the specific requirements for creating a contribution program to benefit employees.
Sophisticated clients will care because these programs, which allow for both direct employer contributions and employee pre-tax contributions via a Section 125 cafeteria plan, represent a significant new employee benefit. However, adoption requires careful structuring to ensure compliance. The regulations mandate a formal written plan, impose nondiscrimination testing, and establish annual contribution limits ($5,000 total, with a $2,500 cap for employers per employee). The rules also strictly limit investments during a beneficiary's childhood to low-cost funds tracking broad U.S. equity indices, excluding sector-specific or ESG-focused funds. Counsel should advise clients on the necessary plan amendments, payroll procedures, and compliance checks required to offer this b
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A new implementing regulation provides long-awaited operational detail on consent, documentation, impact assessments, and cross-border data transfers, with a compliance deadline of January 16, 2027.
Indonesia has published Government Regulation No. 33 of 2026, the long-awaited implementing regulation for its 2022 Personal Data Protection (PDP) Law, which will take effect on January 16, 2027. The regulation provides concrete operational rules that had been missing since the PDP Law's passage, creating clearer compliance obligations for any organization processing the personal data of Indonesian subjects. The new rules specify detailed conditions for obtaining explicit consent and establish minimum content requirements for records of processing activities (ROPAs) and data retention policies. The regulation also clarifies when a data protection impact assessment (DPIA) is required, expressly including processing that involves AI and machine learning. For cross-border data transfers, it establishes a three-tiered framework based on recipient-country adequacy, contractual safeguards, or, as a last resort, data-subject consent. Because Indonesia's Personal Data Protection Authority has not yet been established, key mechanisms like an adequacy list and standard contractual clauses are
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A defendant's litigation conduct before class certification can waive its right to arbitrate, the Seventh Circuit ruled, also clarifying its standard of review for such waiver decisions.
The U.S. Court of Appeals for the Seventh Circuit has affirmed that a defendant can waive its right to compel arbitration through its litigation conduct before a class is even certified. In a Telephone Consumer Protection Act (TCPA) case, the defendant participated in merits-based litigation for more than four years—including filing pleadings, conducting discovery, moving for summary judgment, and opposing class certification—without mentioning arbitration. The court found this prolonged engagement demonstrated an intent to litigate in court, thereby waiving the right to later move the dispute to arbitration after the class was certified. The panel rejected the defendant's excuse that newly hired counsel discovered the arbitration agreements, stating that a late-game change in lawyers cannot excuse a lack of diligence. For class-action defendants, this decision underscores the critical need to identify and assert arbitration rights at the earliest stages of litigation in the Seventh Circuit. It forecloses a 'wait-and-see' approach. The court also altered its appellate standard for re
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A Delaware Court of Chancery decision dismissing a shareholder oversight lawsuit against Boeing's board reaffirms the high legal bar plaintiffs face in proving directors acted in bad faith regarding risk management.
The Delaware Court of Chancery dismissed a shareholder failure-of-oversight lawsuit against Boeing’s board, reinforcing the formidable barrier plaintiffs face in so-called 'Caremark' claims. The derivative suit followed a 2024 incident where a door plug detached from an aircraft mid-flight. Despite the serious safety failure, the court found the shareholders’ own pleadings described a board that was “attentive to safety,” with established committees and extensive risk reporting mechanisms. The opinion, from a justice recently elevated to the Delaware Supreme Court, held that the materialization of a known risk does not itself imply a breach of fiduciary duty; plaintiffs must plead facts showing a conscious dereliction of duty. For sophisticated counsel and their clients, this ruling provides significant comfort that Delaware courts will not second-guess the good-faith risk management decisions of a reasonably engaged board. The decision strongly reaffirms the state’s director-friendly business judgment rule, a key talking point for Delaware as other states compete to attract corporat
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The First Circuit affirmed an injunction against a federal freeze on awarded infrastructure and energy funds, clarifying APA review for broad executive actions but limiting courts' power to compel direct payments.
The U.S. Court of Appeals for the First Circuit largely upheld a preliminary injunction blocking a federal government freeze on funds already awarded to grantees under the Infrastructure Investment and Jobs Act (IIJA) and the Inflation Reduction Act (IRA). The court held that the administration's categorical directive to pause disbursements was likely a reviewable final agency action under the Administrative Procedure Act (APA), not an unchallengeable 'programmatic attack.' Sophisticated counsel should note the court’s reasoning on several key administrative law principles. First, it found the agencies likely acted arbitrarily and capriciously by instituting a 'freeze first, ask questions later' policy without considering the grantees' significant reliance interests on the awarded funds. Second, the court carefully distinguished between permissible and impermissible remedies; while it affirmed the injunction blocking the government from implementing the unlawful freeze, it vacated the portion of the lower court's order that compelled specific payments, citing sovereign immunity conce
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The SEC published a notice on an application to let a registered interval fund simultaneously offer exchange-listed and blockchain-tokenized share classes alongside its periodic repurchase shares.
Under the application, a 1940 Act interval fund would add an exchange-listed share class providing continuous intraday liquidity and a tokenized class traded on ATSs or other quotation media, while retaining its existing repurchase-only interval fund classes. The relief would amend a November 2025 exemptive order that conditioned multiclass relief on shares not being listed or traded on any secondary market, a condition the SEC has consistently imposed on recent interval fund and BDC multiclass orders. Applicants are seeking exemptions from Investment Company Act Sections 18(a)(2), 18(c), and 18(i), Rule 23c-3, and Section 17(d)/Rule 17d-1, with additional conditions requiring that any premium or below-NAV issuance apply uniformly across all share classes. The hearing-request window runs through September 18, 2026; an order will be granted unless the SEC calls a hearing. For fund sponsors, this signals potential SEC openness to hybrid registered products that broaden retail and institutional access to private-market strategies while still permitting holdings of illiquid assets, and c
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A new bill would eliminate the private right of action for CIPA pen-register claims, but a recent appellate ruling and alternative legal theories mean website operators are not out of the woods.
California's legislature and one of its appellate courts have issued conflicting signals on the future of website tracking litigation. The legislature has passed and sent to the governor SB 690, a bill that would eliminate the private right of action under the California Invasion of Privacy Act’s (CIPA) pen-register provision, a favorite tool of plaintiffs' lawyers targeting common cookies and analytics pixels. If signed, the law would apply retroactively. At the same time, the California Court of Appeal issued a tentative ruling in Variety Media, LLC v. Superior Court holding that CIPA’s pen-register definition is technology-neutral and can apply to internet communications. While the court rejected the specific claim because an IP address identifies a communication's source rather than its destination, the broader interpretation is a setback for defendants. Sophisticated counsel should not view SB 690 as a complete solution; instead, they should anticipate plaintiffs will pivot back to other CIPA provisions, such as Section 631(a) wiretapping claims, or pursue other common-law priva
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Proposed regulations would implement a daily proration method for determining a U.S. shareholder's pro rata share of a CFC's subpart F and tested income, replacing the previous year-end ownership test.
The U.S. Treasury Department and IRS have released proposed regulations detailing new rules for determining a U.S. shareholder’s income inclusion from a controlled foreign corporation (CFC). The regulations implement statutory changes that replace the long-standing test based on ownership on the last day of the year with a daily proration method for allocating a CFC's subpart F income and tested income. These changes will significantly affect U.S. multinationals, altering how they calculate their tax liability on foreign earnings, particularly in years involving acquisitions or dispositions of CFC stock.
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The Colorado Attorney General's Office has scheduled an October 26, 2026, hearing on proposed rules to implement the state's new AI law, seeking public comment on key definitions affecting employers that use automated decision-making tools.
Colorado’s Attorney General has released draft rules to implement the state's new Automated Decision-Making Technology (ADMT) Act, scheduling a public hearing for October 26, 2026, to gather stakeholder input. The act, effective January 1, 2027, governs the use of AI in "consequential" employment decisions such as hiring, promotion, and termination. The proposed regulations are significant for employers because they will clarify ambiguous but critical statutory terms. The AG is specifically soliciting comment on two competing standards for when an AI tool "materially influences" a decision, a key trigger for the Act’s obligations. A lower threshold could subject a wide range of common HR technologies to the new requirements. The rulemaking will also address the allocation of compliance responsibilities between employers and the third-party vendors who often develop and operate these AI tools, which will directly impact risk management, vendor contracts, and procurement strategies. Stakeholders can submit written comments until the date of the hearing to help shape the final rules.
New data shows a significant drop in the duration of Second Request investigations in the first half of 2026, offering potential relief for dealmakers facing in-depth antitrust scrutiny.
An analysis of federal data indicates that extended 'Second Request' antitrust merger reviews are concluding more quickly in 2026, a welcome development for dealmakers. According to a report from Akin Gump, the average review time for investigations resulting in a published agency outcome fell below 10 months in the first half of the year, down from historical highs of over 12 months in 2025. Investigations that closed without a public statement were even faster, averaging around eight months. For sophisticated counsel and their clients, this trend is a significant factor in deal planning. Protracted reviews can jeopardize transactions by increasing costs and uncertainty. The reported shortening of timelines, linked to a greater agency willingness to accept settlements, may provide more predictability and reduce regulatory friction for strategic M&A. Practitioners should continue to track this data to see if the trend holds and adjust their strategies for negotiating with enforcement agencies accordingly, particularly regarding potential remedies.
Forthcoming changes to the FTSE UK Index Series eligibility rules will lower the minimum free-float requirement, potentially opening the indices to a wider range of companies.
FTSE Russell is set to change the eligibility criteria for its UK Index Series by lowering the minimum free-float percentage required for a company's shares. The move is designed to make London's public markets more attractive and accessible. This change is significant for companies with large, concentrated ownership bases, such as founder-led businesses or those backed by private equity or sovereign wealth funds, which may have previously struggled to meet the threshold. Inclusion in a major FTSE index can substantially boost a company's market profile, trading liquidity, and access to capital from institutional and index-tracking investors. For corporate and capital markets counsel, this development alters the strategic calculus for advising clients on IPOs and listing venues, potentially making a London listing more viable for a new class of issuers. Lawyers should watch for the final rule details and implementation date and advise relevant clients to reassess their capital-raising and listing strategies in light of the new flexibility.
A California appellate court held that municipalities can deny affordable housing projects under the Housing Accountability Act's 'builder's remedy' if the proposed land use violates a certified Local Coastal Program.
A California Court of Appeal held that the state's Coastal Act takes precedence over the Housing Accountability Act’s (HAA) powerful “builder’s remedy.” In 'New Commune DTLA LLC v. City of Redondo Beach,' the court affirmed a city's denial of a mixed-use project that included affordable housing because the proposed residential use was not permitted under the city’s California Coastal Commission-certified Local Coastal Program (LCP).
This is the first appellate decision to directly resolve the tension between these two statutes, clarifying that the builder's remedy cannot be used to bypass fundamental land use restrictions in an LCP. The ruling provides coastal municipalities with a firm legal basis to reject otherwise-eligible HAA projects that conflict with coastal zoning, even if the municipality lacks a compliant state housing plan. For developers, the decision curtails a key strategy for forcing project approvals in the valuable coastal zone and underscores the need to ensure proposed uses conform to the LCP at the outset. The court signaled that any recalibration of the balance
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An en banc panel affirmed that federal agencies cannot require health plans to include non-negotiated 'ghost rates' or exclude incentive bonuses when calculating a key benchmark for out-of-network payment disputes.
The en banc Fifth Circuit affirmed a district court ruling that invalidated key parts of federal rules for calculating the Qualifying Payment Amount (QPA) under the No Surprises Act. In Texas Medical Association v. HHS, the court held that the government's methodology improperly deflated this key statutory benchmark by including non-negotiated "ghost rates" for services that providers do not actually offer and by excluding certain bonus and incentive payments from the calculation.
Counsel for both payors and providers should care because the QPA is a central reference point for patient cost-sharing and for arbitrations over out-of-network bills. The court noted that the flawed, "artificially low" QPA calculation had "upended" the statutory dispute resolution process, citing the massive volume of arbitrations that providers have won. This ruling solidifies a more provider-favorable calculation method, directly impacting negotiation leverage and the financial outcomes of payment disputes nationwide.
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Reviving a long-running suit over subprime mortgage disclosures, the court endorsed a 'price-maintenance' theory and clarified how plaintiffs can show market efficiency.
The U.S. Court of Appeals for the Sixth Circuit revived a securities fraud class action against Freddie Mac and its former officers stemming from the 2008 financial crisis. The panel reversed a district court's summary judgment ruling and denial of class certification, finding genuine disputes of material fact as to whether the defendants made false statements about their subprime mortgage exposure.
Sophisticated counsel should note the court's endorsement of the 'price-maintenance' theory, which allows claims based on misrepresentations that artificially maintain a stock price, even without causing an increase. Critically, the court held that structural evidence of an efficient market—such as high trading volume, extensive analyst coverage, and numerous market makers—was sufficient to establish a presumption of reliance. The lower court erred by giving dispositive weight to a lack of immediate stock price movement after news. This guidance lowers a key hurdle for plaintiffs at class certification.
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A significant disgorgement award for infringement of ice cream packaging design serves as a potent reminder for brand owners to protect and enforce their trade dress rights.
A nearly $24 million disgorgement award in a dispute over ice cream packaging has underscored the significant financial risks associated with trade dress infringement. The decision reinforces the value of a product's packaging and overall configuration as a protectable intellectual property asset for brand owners. For companies, particularly in the competitive consumer packaged goods sector, the ruling is a powerful reminder that distinctive branding extends beyond logos and names to the "look and feel" of a product on the shelf. Sophisticated counsel should advise clients that this substantial award may embolden rights holders to more aggressively police and litigate against copycat packaging. The key takeaway is the need for rigorous design clearance processes before launching new products and a proactive strategy to secure and enforce trade dress rights. Brand owners should assess whether their own packaging has acquired the distinctiveness necessary for protection and consider registration to strengthen their market position.
The FTC has proposed an enforcement policy signaling that undisclosed data-driven individualized pricing may be deceptive or unfair, with broad disclosure and consent expectations across industries.
On August 19, 2026, the FTC voted to seek public comment on a draft Enforcement Policy Statement addressing personalized pricing—using consumer-specific data to estimate willingness to pay and set individualized prices. The proposal does not ban the practice but applies Section 5 deception and unfairness principles, requiring clear and conspicuous disclosure that a price is personalized, the basis for the personalization, and the data categories used. The FTC also suggests that concealed personalized pricing may be unfair because consumers cannot reasonably avoid monetary harm they do not know about, and that some practices could require affirmative consent beyond current privacy norms. Notable examples flag enforcement concern where data signals urgency, vulnerability, or lack of alternatives—medical need, travel for a funeral, inability to leave home, or geolocation inside a store. Sophisticated counsel should advise retail, travel, healthcare-adjacent, and adtech clients to map consumer-level price variation, audit pricing algorithms and vendor data flows, update privacy notices,
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The D.C. Circuit has reversed longstanding FDA practice on 180-day generic drug exclusivity, holding that a first-filer's failure to obtain timely tentative approval is only excused if an agency delay was the 'but-for' cause.
In a significant ruling for generic drug manufacturers, the D.C. Circuit rejected the FDA's long-standing 'multiple sufficient causes' test for an exception to the forfeiture of 180-day market exclusivity. Previously, the FDA allowed a first Abbreviated New Drug Application (ANDA) filer to retain its valuable exclusivity if a change in approval requirements was merely one of several reasons for failing to obtain tentative approval within the statutory 30-month window.
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New data shows a significant drop in the duration of Second Request investigations in the first half of 2026, offering potential relief for dealmakers facing in-depth antitrust scrutiny.
An analysis of federal data indicates that extended 'Second Request' antitrust merger reviews are concluding more quickly in 2026, a welcome development for dealmakers. According to a report from Akin Gump, the average review time for investigations resulting in a published agency outcome fell below 10 months in the first half of the year, down from historical highs of over 12 months in 2025. Investigations that closed without a public statement were even faster, averaging around eight months. For sophisticated counsel and their clients, this trend is a significant factor in deal planning. Protracted reviews can jeopardize transactions by increasing costs and uncertainty. The reported shortening of timelines, linked to a greater agency willingness to accept settlements, may provide more predictability and reduce regulatory friction for strategic M&A. Practitioners should continue to track this data to see if the trend holds and adjust their strategies for negotiating with enforcement agencies accordingly, particularly regarding potential remedies.
The Federal Trade Commission has released a proposed enforcement policy statement indicating it will use Section 5 of the FTC Act to target undisclosed or deceptive personalized pricing practices.
The U.S. Federal Trade Commission is targeting personalized and dynamic pricing with a newly proposed enforcement policy statement. The announcement signals the agency's intent to use its authority under Section 5 of the FTC Act, which prohibits unfair or deceptive acts, to scrutinize businesses that use consumer data to set individualized prices. The policy, which is not a formal rule or ban, focuses on transparency and fairness. It posits that failing to clearly disclose that prices are personalized, the basis for the personalization, and the types of data used may be an unfair or deceptive practice. The FTC also highlighted concerns about deceptive framing, such as presenting a higher price as a special discount, and unfairness that occurs when concealment prevents consumers from avoiding harm. The proposal provides several examples of potentially unlawful conduct, including a delivery service charging higher prices to consumers whose data suggests they are homebound. The agency is seeking public comment on the proposal.
Private equity giant KKR will acquire medical device manufacturer Integer Holdings Corp. in a going-private transaction valued at approximately $5.7 billion.
Global investment firm KKR has entered into a definitive agreement to acquire Integer Holdings Corp., a publicly traded medical device contract manufacturer, for approximately $5.7 billion. The all-cash transaction will result in Integer becoming a privately held company. Integer, whose brands include Greatbatch Medical and Lake Region Medical, specializes in the cardio and vascular, neuromodulation, and cardiac rhythm management markets.
For sophisticated counsel and their clients, this deal underscores the continued strength and appetite of private equity for large-scale acquisitions in the healthcare and life sciences sectors. The significant valuation serves as a key market indicator for other companies in the medtech space and highlights the viability of take-private transactions as an exit strategy. This move signals a robust pipeline for transactional practices and may prompt other PE firms and strategic acquirers to evaluate similar targets. The transaction is expected to close by the end of the year, subject to customary closing conditions.
A Delaware Court of Chancery decision dismissing a shareholder oversight lawsuit against Boeing's board reaffirms the high legal bar plaintiffs face in proving directors acted in bad faith regarding risk management.
The Delaware Court of Chancery dismissed a shareholder failure-of-oversight lawsuit against Boeing’s board, reinforcing the formidable barrier plaintiffs face in so-called 'Caremark' claims. The derivative suit followed a 2024 incident where a door plug detached from an aircraft mid-flight. Despite the serious safety failure, the court found the shareholders’ own pleadings described a board that was “attentive to safety,” with established committees and extensive risk reporting mechanisms. The opinion, from a justice recently elevated to the Delaware Supreme Court, held that the materialization of a known risk does not itself imply a breach of fiduciary duty; plaintiffs must plead facts showing a conscious dereliction of duty. For sophisticated counsel and their clients, this ruling provides significant comfort that Delaware courts will not second-guess the good-faith risk management decisions of a reasonably engaged board. The decision strongly reaffirms the state’s director-friendly business judgment rule, a key talking point for Delaware as other states compete to attract corporat
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New proposed regulations establish the framework for employer contributions to 'Trump Accounts,' including plan document, nondiscrimination, and investment-limitation rules.
The U.S. Treasury and IRS have released proposed regulations detailing the operational framework for "Trump Accounts," a new type of tax-advantaged savings vehicle for children. The guidance is critical for employers, as it outlines the specific requirements for creating a contribution program to benefit employees.
Sophisticated clients will care because these programs, which allow for both direct employer contributions and employee pre-tax contributions via a Section 125 cafeteria plan, represent a significant new employee benefit. However, adoption requires careful structuring to ensure compliance. The regulations mandate a formal written plan, impose nondiscrimination testing, and establish annual contribution limits ($5,000 total, with a $2,500 cap for employers per employee). The rules also strictly limit investments during a beneficiary's childhood to low-cost funds tracking broad U.S. equity indices, excluding sector-specific or ESG-focused funds. Counsel should advise clients on the necessary plan amendments, payroll procedures, and compliance checks required to offer this b
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The Colorado Attorney General's Office has scheduled an October 26, 2026, hearing on proposed rules to implement the state's new AI law, seeking public comment on key definitions affecting employers that use automated decision-making tools.
Colorado’s Attorney General has released draft rules to implement the state's new Automated Decision-Making Technology (ADMT) Act, scheduling a public hearing for October 26, 2026, to gather stakeholder input. The act, effective January 1, 2027, governs the use of AI in "consequential" employment decisions such as hiring, promotion, and termination. The proposed regulations are significant for employers because they will clarify ambiguous but critical statutory terms. The AG is specifically soliciting comment on two competing standards for when an AI tool "materially influences" a decision, a key trigger for the Act’s obligations. A lower threshold could subject a wide range of common HR technologies to the new requirements. The rulemaking will also address the allocation of compliance responsibilities between employers and the third-party vendors who often develop and operate these AI tools, which will directly impact risk management, vendor contracts, and procurement strategies. Stakeholders can submit written comments until the date of the hearing to help shape the final rules.
A new executive order invokes national emergency powers to prohibit or condition transactions involving foreign-made electric grid equipment from certain countries, citing national security risks.
The President has issued Executive Order 14420, declaring a national emergency to address foreign threats to the U.S. bulk-power system. Invoking the International Emergency Economic Powers Act (IEEPA), the order creates a new security review process and generally bars the acquisition or installation of bulk-power system equipment from designated 'Covered Foreign Entities'—initially including countries under U.S. sanctions or arms embargoes like China and Russia.
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A new executive order allows the Department of Energy to block power-grid equipment from foreign adversaries like China and Russia, creating immediate supply-chain uncertainty for energy and data-center projects.
A new U.S. executive order declares a national emergency to secure the bulk-power system (BPS), creating significant uncertainty for energy and data-center infrastructure projects. The order invokes the International Emergency Economic Powers Act to authorize the Department of Energy (DOE) to prohibit or impose conditions on transactions involving BPS equipment designed, manufactured, or supplied by entities with ties to designated foreign adversaries, including China and Russia. The rule applies to transactions initiated after August 26, 2026, and its broad scope covers critical hardware like transformers, turbines, inverters, and battery energy storage systems, as well as associated software, firmware, and digital services. Sophisticated counsel should advise clients that the order also empowers the DOE to regulate already-installed equipment, though immediate replacement mandates are not anticipated. Project developers, suppliers, and financiers must now conduct urgent supply-chain diligence and revise contracts to allocate potential costs from procurement delays, equipment substi
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A new executive order declares a national emergency and directs the Department of Energy to create rules restricting the acquisition and use of bulk-power system electric equipment from designated foreign adversaries.
A new executive order declares a national emergency to address security threats to the U.S. bulk-power system from foreign adversaries. The order prohibits, subject to future regulation, the acquisition, importation, or installation of specified electric-grid equipment manufactured or supplied by persons controlled by or subject to the jurisdiction of a "Covered Foreign Entity." While not self-executing, it directs the Department of Energy to publish implementing rules within 120 days. This action signals a major U.S. policy shift to secure critical infrastructure supply chains. Energy companies, equipment suppliers, and data center operators must now assess their reliance on foreign-produced components, which could range from large transformers to industrial control systems. The order also directs federal procurement agencies to prioritize U.S.-manufactured energy infrastructure. Counsel should monitor the upcoming DoE rulemaking, which will establish licensing and mitigation procedures, and could compel the replacement of currently installed equipment.
The D.C. Circuit has reversed longstanding FDA practice on 180-day generic drug exclusivity, holding that a first-filer's failure to obtain timely tentative approval is only excused if an agency delay was the 'but-for' cause.
In a significant ruling for generic drug manufacturers, the D.C. Circuit rejected the FDA's long-standing 'multiple sufficient causes' test for an exception to the forfeiture of 180-day market exclusivity. Previously, the FDA allowed a first Abbreviated New Drug Application (ANDA) filer to retain its valuable exclusivity if a change in approval requirements was merely one of several reasons for failing to obtain tentative approval within the statutory 30-month window.
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A New York bill introduced after the legislative session would opt the state out of DIDMCA interest-rate preemption for loans to residents, signaling a major 2027 fight for out-of-state banks and their fintech partners.
A New York state senator has introduced legislation that would opt the state out of the Depository Institutions Deregulation and Monetary Control Act of 1980 (DIDMCA). This federal law allows federally insured, state-chartered banks to charge interest at rates permitted by their home state, regardless of the borrower's location. The bill would subject consumer loans "made" in New York to the state's own interest-rate limits, including its 25% criminal usury cap.
This matters because New York is the nation’s fourth-largest state, and its withdrawal from the DIDMCA framework would substantially increase regulatory risk for interstate lending programs, particularly those involving fintech partners. The bill broadly defines a loan as being "made" in New York if the borrower is a resident, a definition that is already the subject of federal litigation concerning opt-out laws in Colorado and Oregon.
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The SEC has advanced its crypto custody rule, the OCC and FDIC have finalized the definition of an 'unsafe or unsound' practice, and the CFTC is moving on swap execution facility rules.
Multiple US financial regulators have advanced significant rulemakings. The SEC submitted proposed amendments to its custody rules to the White House for review, which are intended to modernize the framework for investment advisers, particularly regarding crypto assets. The text is not yet public, but the agency's agenda targets October 2026 for a notice of proposed rulemaking. Separately, the OCC and FDIC issued a joint final rule defining an 'unsafe or unsound practice.' This narrows the grounds on which examiners can issue supervisory warnings, or MRAs, potentially providing more certainty for banks serving digital asset businesses by tying MRAs to practices that could cause material financial harm or violate a law. Concurrently, the CFTC proposed eliminating the order book requirement for certain swap execution facility transactions, while the comment period closed on a joint SEC-CFTC effort to clarify derivatives definitions, drawing comments on whether sports-wagering contracts qualify as swaps.
The Colorado Attorney General alleges a California-based earned wage access provider is operating an unlicensed, high-cost lending program in violation of state consumer credit and protection laws.
Colorado's Attorney General and its top consumer credit regulator have sued a California-based financial technology company, alleging its earned wage access (EWA) product is a disguised high-cost loan that violates state law. The complaint, filed in state court, argues that the product functions as a loan because consumers must pre-authorize debits, cannot easily revoke that authorization, and are encouraged to pay "tips" that act as undisclosed finance charges.
The lawsuit is a major development in the burgeoning EWA market, which often operates in a gray area of state lending laws. For fintech firms, their financial institution partners, and employers offering these products, this action highlights significant regulatory risk. A ruling that EWA products are loans subject to state licensing, disclosure, and usury laws could reshape the industry's business model. Counsel should monitor this case for its potential to set a precedent in Colorado and to inspire similar enforcement actions by other state regulators examining the EWA space.
The U.S. Treasury's financial-crimes unit has issued new guidance and sanctions targeting a cross-border fuel smuggling and money laundering scheme operated by Mexican cartels.
On June 30, 2026, the Treasury's Financial Crimes Enforcement Network (FinCEN) issued an alert detailing a scheme by Mexican cartels to smuggle U.S.-sourced fuel into Mexico to evade import taxes. The scheme relies on U.S. financial institutions to process payments—including wire transfers and stablecoins—and launder the proceeds. In a parallel action, the Office of Foreign Assets Control (OFAC) sanctioned two individuals and nine entities for their roles in the operation.
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The CFTC chairman has directed staff to explore creating a market structure for digital assets under the agency's current powers, citing stalled legislation.
In a significant policy signal, CFTC Chairman Michael Selig has directed agency staff to explore using existing authority to establish a market structure for crypto assets. The move comes amid concerns that the CLARITY Act, a bipartisan legislative effort to regulate digital assets, may not pass Congress in a timely manner. This directive could bypass the legislative stalemate and create a regulatory framework for digital asset markets directly through the CFTC's rulemaking process. For financial institutions and crypto-native firms, this development presents both opportunities and challenges. A formal CFTC-regulated market could provide much-needed legal clarity, potentially allowing crypto exchanges to register as a new type of designated contract market (DCM) for leveraged trading. However, it would also introduce new compliance and oversight burdens. Legal and compliance teams should closely monitor the CFTC for any forthcoming proposed rules and prepare to engage with the rulemaking process, as the outcome could reshape US digital asset trading and DeFi protocol operations.
An en banc panel affirmed that federal agencies cannot require health plans to include non-negotiated 'ghost rates' or exclude incentive bonuses when calculating a key benchmark for out-of-network payment disputes.
The en banc Fifth Circuit affirmed a district court ruling that invalidated key parts of federal rules for calculating the Qualifying Payment Amount (QPA) under the No Surprises Act. In Texas Medical Association v. HHS, the court held that the government's methodology improperly deflated this key statutory benchmark by including non-negotiated "ghost rates" for services that providers do not actually offer and by excluding certain bonus and incentive payments from the calculation.
Counsel for both payors and providers should care because the QPA is a central reference point for patient cost-sharing and for arbitrations over out-of-network bills. The court noted that the flawed, "artificially low" QPA calculation had "upended" the statutory dispute resolution process, citing the massive volume of arbitrations that providers have won. This ruling solidifies a more provider-favorable calculation method, directly impacting negotiation leverage and the financial outcomes of payment disputes nationwide.
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A significant disgorgement award for infringement of ice cream packaging design serves as a potent reminder for brand owners to protect and enforce their trade dress rights.
A nearly $24 million disgorgement award in a dispute over ice cream packaging has underscored the significant financial risks associated with trade dress infringement. The decision reinforces the value of a product's packaging and overall configuration as a protectable intellectual property asset for brand owners. For companies, particularly in the competitive consumer packaged goods sector, the ruling is a powerful reminder that distinctive branding extends beyond logos and names to the "look and feel" of a product on the shelf. Sophisticated counsel should advise clients that this substantial award may embolden rights holders to more aggressively police and litigate against copycat packaging. The key takeaway is the need for rigorous design clearance processes before launching new products and a proactive strategy to secure and enforce trade dress rights. Brand owners should assess whether their own packaging has acquired the distinctiveness necessary for protection and consider registration to strengthen their market position.
A defendant's litigation conduct before class certification can waive its right to arbitrate, the Seventh Circuit ruled, also clarifying its standard of review for such waiver decisions.
The U.S. Court of Appeals for the Seventh Circuit has affirmed that a defendant can waive its right to compel arbitration through its litigation conduct before a class is even certified. In a Telephone Consumer Protection Act (TCPA) case, the defendant participated in merits-based litigation for more than four years—including filing pleadings, conducting discovery, moving for summary judgment, and opposing class certification—without mentioning arbitration. The court found this prolonged engagement demonstrated an intent to litigate in court, thereby waiving the right to later move the dispute to arbitration after the class was certified. The panel rejected the defendant's excuse that newly hired counsel discovered the arbitration agreements, stating that a late-game change in lawyers cannot excuse a lack of diligence. For class-action defendants, this decision underscores the critical need to identify and assert arbitration rights at the earliest stages of litigation in the Seventh Circuit. It forecloses a 'wait-and-see' approach. The court also altered its appellate standard for re
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A new implementing regulation provides long-awaited operational detail on consent, documentation, impact assessments, and cross-border data transfers, with a compliance deadline of January 16, 2027.
Indonesia has published Government Regulation No. 33 of 2026, the long-awaited implementing regulation for its 2022 Personal Data Protection (PDP) Law, which will take effect on January 16, 2027. The regulation provides concrete operational rules that had been missing since the PDP Law's passage, creating clearer compliance obligations for any organization processing the personal data of Indonesian subjects. The new rules specify detailed conditions for obtaining explicit consent and establish minimum content requirements for records of processing activities (ROPAs) and data retention policies. The regulation also clarifies when a data protection impact assessment (DPIA) is required, expressly including processing that involves AI and machine learning. For cross-border data transfers, it establishes a three-tiered framework based on recipient-country adequacy, contractual safeguards, or, as a last resort, data-subject consent. Because Indonesia's Personal Data Protection Authority has not yet been established, key mechanisms like an adequacy list and standard contractual clauses are
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A new bill would eliminate the private right of action for CIPA pen-register claims, but a recent appellate ruling and alternative legal theories mean website operators are not out of the woods.
California's legislature and one of its appellate courts have issued conflicting signals on the future of website tracking litigation. The legislature has passed and sent to the governor SB 690, a bill that would eliminate the private right of action under the California Invasion of Privacy Act’s (CIPA) pen-register provision, a favorite tool of plaintiffs' lawyers targeting common cookies and analytics pixels. If signed, the law would apply retroactively. At the same time, the California Court of Appeal issued a tentative ruling in Variety Media, LLC v. Superior Court holding that CIPA’s pen-register definition is technology-neutral and can apply to internet communications. While the court rejected the specific claim because an IP address identifies a communication's source rather than its destination, the broader interpretation is a setback for defendants. Sophisticated counsel should not view SB 690 as a complete solution; instead, they should anticipate plaintiffs will pivot back to other CIPA provisions, such as Section 631(a) wiretapping claims, or pursue other common-law priva
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The FTC has proposed an enforcement policy signaling that undisclosed data-driven individualized pricing may be deceptive or unfair, with broad disclosure and consent expectations across industries.
On August 19, 2026, the FTC voted to seek public comment on a draft Enforcement Policy Statement addressing personalized pricing—using consumer-specific data to estimate willingness to pay and set individualized prices. The proposal does not ban the practice but applies Section 5 deception and unfairness principles, requiring clear and conspicuous disclosure that a price is personalized, the basis for the personalization, and the data categories used. The FTC also suggests that concealed personalized pricing may be unfair because consumers cannot reasonably avoid monetary harm they do not know about, and that some practices could require affirmative consent beyond current privacy norms. Notable examples flag enforcement concern where data signals urgency, vulnerability, or lack of alternatives—medical need, travel for a funeral, inability to leave home, or geolocation inside a store. Sophisticated counsel should advise retail, travel, healthcare-adjacent, and adtech clients to map consumer-level price variation, audit pricing algorithms and vendor data flows, update privacy notices,
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A California appellate court held that municipalities can deny affordable housing projects under the Housing Accountability Act's 'builder's remedy' if the proposed land use violates a certified Local Coastal Program.
A California Court of Appeal held that the state's Coastal Act takes precedence over the Housing Accountability Act’s (HAA) powerful “builder’s remedy.” In 'New Commune DTLA LLC v. City of Redondo Beach,' the court affirmed a city's denial of a mixed-use project that included affordable housing because the proposed residential use was not permitted under the city’s California Coastal Commission-certified Local Coastal Program (LCP).
This is the first appellate decision to directly resolve the tension between these two statutes, clarifying that the builder's remedy cannot be used to bypass fundamental land use restrictions in an LCP. The ruling provides coastal municipalities with a firm legal basis to reject otherwise-eligible HAA projects that conflict with coastal zoning, even if the municipality lacks a compliant state housing plan. For developers, the decision curtails a key strategy for forcing project approvals in the valuable coastal zone and underscores the need to ensure proposed uses conform to the LCP at the outset. The court signaled that any recalibration of the balance
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A Fourth Circuit panel invalidated the FCC's lowest unit charge guidance for political ads and held that the agency cannot shield bureau-level decisions from judicial review.
The U.S. Court of Appeals for the Fourth Circuit has invalidated Federal Communications Commission guidance on calculating the "lowest unit charge" for political advertisements, a key rule for broadcasters. More broadly, the court rejected the FCC's position that decisions issued by its bureaus, rather than the full commission, are not "final agency actions" and are therefore shielded from immediate judicial review.
The ruling has significant consequences for sophisticated counsel and their clients. For media and broadcast companies, it creates immediate uncertainty around the rules for political ad sales, a critical revenue source, especially in an election year. For practitioners across all regulated industries, the decision strengthens their ability to challenge guidance and enforcement advisories issued by agency staff and sub-units without waiting for a formal enforcement action. This holding potentially opens the door to more preemptive litigation against what many regulated entities view as "rulemaking by other means." Counsel should monitor whether the FCC seeks rehearing or
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The First Circuit affirmed an injunction against a federal freeze on awarded infrastructure and energy funds, clarifying APA review for broad executive actions but limiting courts' power to compel direct payments.
The U.S. Court of Appeals for the First Circuit largely upheld a preliminary injunction blocking a federal government freeze on funds already awarded to grantees under the Infrastructure Investment and Jobs Act (IIJA) and the Inflation Reduction Act (IRA). The court held that the administration's categorical directive to pause disbursements was likely a reviewable final agency action under the Administrative Procedure Act (APA), not an unchallengeable 'programmatic attack.' Sophisticated counsel should note the court’s reasoning on several key administrative law principles. First, it found the agencies likely acted arbitrarily and capriciously by instituting a 'freeze first, ask questions later' policy without considering the grantees' significant reliance interests on the awarded funds. Second, the court carefully distinguished between permissible and impermissible remedies; while it affirmed the injunction blocking the government from implementing the unlawful freeze, it vacated the portion of the lower court's order that compelled specific payments, citing sovereign immunity conce
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Policymakers are considering designating certain drug cartels as Foreign Terrorist Organizations and using FinCEN special measures, a move with profound compliance implications for US businesses.
A recent analysis highlights a growing policy debate in Washington over treating certain transnational drug cartels as national security threats, rather than purely criminal enterprises. Proponents of this shift advocate for deploying potent legal tools, including designating cartels as Foreign Terrorist Organizations (FTOs) and subjecting them to 'special measures' by the Financial Crimes Enforcement Network (FinCEN) under Section 311 of the USA PATRIOT Act.
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The SEC has proposed Regulation Crypto Assets, a new framework creating tailored registration exemptions, disclosure rules, and a transition path for crypto offerings structured as investment contracts.
The U.S. Securities and Exchange Commission has proposed "Regulation Crypto Assets," a landmark rulemaking intended to shift from regulation-by-enforcement to a clear framework for digital asset offerings. The proposal creates two new exemptions from Securities Act registration for crypto assets sold as part of an investment contract: a "Startup Exemption" for offerings up to $5 million and a tiered "Fundraising Exemption," modeled on Regulation A, for raises up to $75 million. For sophisticated counsel, the rule provides the first defined pathways for clients to raise capital in the crypto space while complying with federal securities laws. It also introduces a principles-based disclosure regime tailored to crypto and a novel safe harbor allowing an investment contract to "cease to exist" once the issuer's essential managerial efforts are complete. This provides a potential off-ramp from securities regulation for mature, decentralized projects. Market participants should monitor the 60-day comment period and consider the proposal's interaction with pending federal legislation.
The SEC has consolidated nationwide accounting and reporting expertise into a new Enforcement Division unit, signaling an expected uptick in financial-reporting cases against public companies and their auditors.
On August 5, 2026, the SEC announced formation of a dedicated Financial Reporting and Accounting Unit within its Division of Enforcement. The new unit merges resources previously dispersed across headquarters and regional offices, concentrating subject-matter expertise on public-company accounting, financial reporting, disclosures, internal controls, and auditor-engagement failures. Enforcement Director David Woodcock has identified financial-reporting matters as a priority, and Chairman Paul Atkins has framed the move as consistent with refocusing SEC enforcement on its core mission. The unit's scope is expected to reach beyond traditional accounting fraud into non-GAAP measures, revenue recognition, channel stuffing, inventory management, and disclosure controls, with heightened scrutiny of audit firms and executive certifications. Counsel advising boards, audit committees, and disclosure committees should expect increased investigative activity and should review internal controls, materiality analyses under SAB 99, risk-factor and MD&A disclosures, and whistleblower procedures, wh
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The SEC published a notice on an application to let a registered interval fund simultaneously offer exchange-listed and blockchain-tokenized share classes alongside its periodic repurchase shares.
Under the application, a 1940 Act interval fund would add an exchange-listed share class providing continuous intraday liquidity and a tokenized class traded on ATSs or other quotation media, while retaining its existing repurchase-only interval fund classes. The relief would amend a November 2025 exemptive order that conditioned multiclass relief on shares not being listed or traded on any secondary market, a condition the SEC has consistently imposed on recent interval fund and BDC multiclass orders. Applicants are seeking exemptions from Investment Company Act Sections 18(a)(2), 18(c), and 18(i), Rule 23c-3, and Section 17(d)/Rule 17d-1, with additional conditions requiring that any premium or below-NAV issuance apply uniformly across all share classes. The hearing-request window runs through September 18, 2026; an order will be granted unless the SEC calls a hearing. For fund sponsors, this signals potential SEC openness to hybrid registered products that broaden retail and institutional access to private-market strategies while still permitting holdings of illiquid assets, and c
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Forthcoming changes to the FTSE UK Index Series eligibility rules will lower the minimum free-float requirement, potentially opening the indices to a wider range of companies.
FTSE Russell is set to change the eligibility criteria for its UK Index Series by lowering the minimum free-float percentage required for a company's shares. The move is designed to make London's public markets more attractive and accessible. This change is significant for companies with large, concentrated ownership bases, such as founder-led businesses or those backed by private equity or sovereign wealth funds, which may have previously struggled to meet the threshold. Inclusion in a major FTSE index can substantially boost a company's market profile, trading liquidity, and access to capital from institutional and index-tracking investors. For corporate and capital markets counsel, this development alters the strategic calculus for advising clients on IPOs and listing venues, potentially making a London listing more viable for a new class of issuers. Lawyers should watch for the final rule details and implementation date and advise relevant clients to reassess their capital-raising and listing strategies in light of the new flexibility.
Reviving a long-running suit over subprime mortgage disclosures, the court endorsed a 'price-maintenance' theory and clarified how plaintiffs can show market efficiency.
The U.S. Court of Appeals for the Sixth Circuit revived a securities fraud class action against Freddie Mac and its former officers stemming from the 2008 financial crisis. The panel reversed a district court's summary judgment ruling and denial of class certification, finding genuine disputes of material fact as to whether the defendants made false statements about their subprime mortgage exposure.
Sophisticated counsel should note the court's endorsement of the 'price-maintenance' theory, which allows claims based on misrepresentations that artificially maintain a stock price, even without causing an increase. Critically, the court held that structural evidence of an efficient market—such as high trading volume, extensive analyst coverage, and numerous market makers—was sufficient to establish a presumption of reliance. The lower court erred by giving dispositive weight to a lack of immediate stock price movement after news. This guidance lowers a key hurdle for plaintiffs at class certification.
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Proposed regulations would implement a daily proration method for determining a U.S. shareholder's pro rata share of a CFC's subpart F and tested income, replacing the previous year-end ownership test.
The U.S. Treasury Department and IRS have released proposed regulations detailing new rules for determining a U.S. shareholder’s income inclusion from a controlled foreign corporation (CFC). The regulations implement statutory changes that replace the long-standing test based on ownership on the last day of the year with a daily proration method for allocating a CFC's subpart F income and tested income. These changes will significantly affect U.S. multinationals, altering how they calculate their tax liability on foreign earnings, particularly in years involving acquisitions or dispositions of CFC stock.
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A guide from Jackson Lewis details critical AI-specific contract terms to manage risk in technology procurement, including disclosure obligations, data use limitations, and liability.
This podcast transcript offers a guide for counsel on navigating the contractual risks of procuring AI technologies or services that use AI. Attorneys highlight the need to update standard agreements to address AI-specific issues, moving beyond traditional software contracts. Key negotiation points include forcing vendor disclosure of AI use, precisely defining "services" to cover AI-driven activities, and scrutinizing data-use clauses, particularly where vendors want to use client data for model training.
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Grade 3 — worth a glance, not the full analysis.
- Treasury launches Quantum-Readiness Task Force for financial sector
Treasury established a public-private task force to help U.S. financial institutions transition to quantum-safe cryptography as future quantum computers could break current encryption protecting financial data and payment systems.
- SBA proposes major overhaul of small business size standards
The SBA's proposed rule would reduce nearly 1,000 size standard categories to 338, potentially reclassifying over 114,000 additional firms as small businesses for federal contracting purposes.
- Washington State Expands Restrictions on Employer Background Checks
An amended state law requires most employers to wait until after a conditional job offer to inquire about criminal history and mandates an individualized assessment before taking adverse action.
- Federal Court Holds FCRA Preempts Texas Medical Debt Reporting Law
A district court in Texas permanently enjoined a state law that barred the reporting of certain out-of-network medical debts, holding that the federal Fair Credit Reporting Act expressly preempts state laws on the subject.
- State Dept. Flags Potential Halt on EB-1 India, EB-2, EB-5 Visas
The US State Department's September 2026 Visa Bulletin holds final action dates steady but warns that high demand may make EB-1 India, all EB-2, and EB-5 Unreserved categories unavailable before the fiscal year ends on September 30.
- Fannie Mae Updates FAQs for New Appraisal Forms and UAD Mandate
Fannie Mae has published updated FAQs for its Uniform Appraisal Dataset (UAD) 3.6 initiative, which becomes mandatory for all new appraisal reports on November 2.
- Maryland Paid Leave Law Creates Bargaining Duty for Union Employers
Maryland’s new paid family leave law gives employers discretion over contribution splits, triggering a duty to bargain with unions over the new payroll deductions before they begin in January 2027.
- State Dept pauses immigrant visa interviews for public charge training
The State Department has temporarily paused immigrant visa interviews worldwide for officer training on new public charge guidance, affecting family, employment, and Diversity Visa categories while nonimmigrant visas remain unaffected.
- UK Supreme Court: Unrecognised Foreign Judgments Can Trigger Insolvency
The UK's top court has confirmed that foreign judgments not recognised under common law rules can still serve as the basis for initiating insolvency proceedings in the UK.
- CMS Allows DME Enrollment Moratorium to Expire
CMS's six-month Medicare enrollment moratorium on certain durable medical equipment suppliers has expired, allowing National Provider Enrollment Contractors to resume accepting initial enrollment applications.
- First BPCIA Suit Filed Over ENTYVIO Biosimilar
Takeda filed the first-ever BPCIA patent infringement lawsuit over a proposed biosimilar for its blockbuster drug ENTYVIO (vedolizumab), targeting Polpharma Biologics in New Jersey federal court.
- Federal Court Upholds Oregon EPR Law in Constitutional First
A federal court on August 27, 2026 issued the first federal ruling addressing constitutionality of a state extended producer responsibility law, upholding Oregon's Plastic Pollution and Recycling Modernization Act.
- AI in AML compliance: human intervention requirements under EU law
Financial institutions using AI for AML/CTF must navigate overlapping requirements from the AI Act, GDPR, and AML Regulation—including the critical Article 76(5) meaningful human intervention standard.
- 2026 proxy season shows governance proposals dominate with 34% average support
Shareholder voting results from the 2026 proxy season reveal continued strong support for governance matters while environmental and social proposals received notably less backing.
- CFPB opposes post-appeal bid to vacate $185M judgment
The consumer finance regulator argues a nonbank lender's motion to vacate a massive judgment for usurious tribal lending is a baseless delay tactic.
- NYC Pied-à-Terre Tax Final Rules Set October Exemption Deadline
New York City's residential-property surcharge on non-primary residences is operational; practitioners must act before October 6, 2026 exemption deadline and January 5, 2027 testing date for the 2027–2028 fiscal year.
- A Practical Guide to W&I Insurance in UK M&A
A new guide for buyers outlines the strategic use of warranty and indemnity insurance in UK M&A, detailing the underwriting process, pricing, key terms, and recent market trends.
- ESMA Consults on EMIR Reporting for Third-Country CCP Clearing
The European Securities and Markets Authority seeks feedback on draft technical standards for new annual reporting on clearing activities at non-EU central counterparties.
- NLRB roadmap targets reversal of Biden-era labor precedents including McLaren Macomb
GC Carey outlines strategy for overturning significant Biden-era NLRB precedents, with employers and unions advised to monitor closely as labor law shifts await.
- 4th Circuit Bars Federal Challenge to State Usury Enforcement
The court held that the Younger abstention doctrine required it to refrain from interfering with Pennsylvania's quasi-criminal enforcement proceeding against an out-of-state title lender accused of charging usurious rates.
- 39 State Bankers Associations Form Blockchain Alliance
The new BankChain Alliance, an industry-owned network, aims to launch in 2027 to provide member institutions with capabilities for tokenized deposits, stablecoins, and smart payments.
- FCC Opens Inquiry on Space Launch Spectrum Needs
The Federal Communications Commission seeks public comment on modernizing spectrum access for the growing commercial and federal space launch and reentry sector.
- Doxo Settles FTC Deceptive Advertising and 'Junk Fee' Complaint
The online bill payment service will pay $2.1 million and is barred from misrepresenting affiliations with billers or the total cost of its service.
- FCA Challenges ATO's OTE Interpretation for Superannuation
The Federal Court of Australia has cast doubt on the ATO's long-held view that OTE includes all earnings except overtime, potentially affecting how employers calculate superannuation contributions for various allowance payments.
- Second Circuit Creates New Three-Part Test for Title VII Religious Accommodation Claims
The Second Circuit confirmed a new three-part test for evaluating prima facie cases in Title VII religious accommodation failures, reshaping employment litigation standards.
- Australia Proposes Work-From-Home Clause in Clerks Award
Australian Fair Work Commission has released draft wording for a work-from-home clause in the Clerks Private Sector Award 2020, establishing a formal request process for employees.
- EMTALA Enforcement Shift: Hospital Accreditors May Gain Compliance Oversight
CMS's July 2026 proposed rule would let accrediting organizations assess EMTALA compliance during hospital surveys, potentially increasing enforcement in states with abortion restrictions.
- FDA approves first FOP treatment Regeneron's PASATRU
The FDA approved Regeneron's PASATRU (garetosmab-grts), the first therapeutic for fibrodysplasia ossificans progressiva, showing a 90%+ reduction in heterotopic ossification lesions.
- Second Circuit adopts indirect purchaser rule for civil RICO
Manufacturers facing civil RICO claims should raise the indirect purchaser rule at the pleading stage as a threshold defense after the Second Circuit became the fourth circuit to adopt this doctrine.
- Virtual & Digital Health Regulatory Digest
A new digest summarizes key virtual and digital health regulatory and public policy developments from July and August 2026 across the US, UK, and EU.
- CalPrivacy fines data broker $116K in first CCPA-Delete Act case
California's privacy regulator penalized LocateSmarter for an overly complicated opt-out process and failing to register as a data broker under the Delete Act.
- 21st Century ROAD to Housing Act becomes law
Bipartisan legislation passed 85-5 in Senate and 358-32 in House targets housing supply through regulatory streamlining and infrastructure tools.
- NYDFS Fines Money Transmitter for Lax Cybersecurity Program
A money transmitter's report of a ransomware attack led to a New York DFS investigation that found broader failures in its required cybersecurity program, resulting in a $250,000 settlement.
- FinCEN Moves to Cut Banque Misr UAE Correspondent Banking Access
FinCEN proposed a rule under Operation Economic Outcast to revoke Banque Misr UAE's correspondent banking access to U.S. financial institutions, targeting Iran's financial access through UAE banks.
- Second Circuit limits FCA scope in wild fish case
The Second Circuit unanimously affirmed that wild fish in public waters do not constitute government "property" under the False Claims Act, dismissing a whistleblower case against Ocean Harvesters with potential $2B exposure.
- FDA Issues FAQ Guidance for Cell and Gene Therapy
The US Food and Drug Administration has published a new guidance document answering frequently asked questions on the development of cellular and gene therapy products, covering topics from IND submissions to clinical trial design.
- 11th Circ. bars arbitration for nonsignatories in crypto case
An Eleventh Circuit court vacated an order compelling nonsignatories to arbitrate crypto-laundering claims because the allegations were grounded in statutory violations, not contractual rights contained in the defendant's terms of use.
- UK court rejects sub-contractor claim over missing project bank account
In E & TL Jones v Vale of Glamorgan Council, the High Court held that a sub-contractor couldn't enforce project bank account provisions against an employer because it wasn't a "Named Supplier" under the NEC4 contract.
- CMS Final Rule Bars Medicaid Funding for Minors' Gender Care
CMS has finalized a rule withdrawing federal Medicaid and CHIP matching funds for gender-affirming procedures furnished to minors, effective October 12, 2026, with a limited tapering period for existing hormone therapy beneficiaries.
- NC Supreme Court Revives Parent Suit Over Student Expulsions
The North Carolina Supreme Court revived a lawsuit against a private school, allowing parents' claims for breach of contract, fraud, and defamation to proceed after their children were expelled allegedly for curriculum complaints.
- States Advance Environmental Justice Rules Despite Federal Rollbacks
Federal EPA moves to narrow Title VI and EJ-focused FOIA rules while states including Pennsylvania, Illinois, New York, and Virginia enact new EJ permitting and planning requirements creating a fragmented regulatory landscape.
- Quebec arbitration allows employer leave bank correction beyond six-month prescription
Quebec arbitrator rules employers can correct leave bank errors years later without being bound by the Labor Code's six-month prescription, but corrections must respect collective agreement rights.