Insights

Do you want your startup to expand and become a major player in your industry? If so, you will most likely need to seek capital from outside investors to help you build infrastructure and fulfill orders.

On September 9, 2026, California Governor Gavin Newsom signed into law SB 813 and AB 1405, creating the nation’s first regulatory framework for AI auditors. And on September 18, Gov. Newsom signed Executive Order N-9-26 (Order) which moved up by about a year some of the implementation deadlines for SB 813 and AB 1405 and convened an expert group to recommend how the Golden State can strengthen existing AI safety laws.

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) establishing a formal framework for the two agencies to share non-public information concerning FDA-regulated products and the companies and individuals engaged in their manufacture, distribution, and sale. The MOU was signed by SEC Chairman Paul S. Atkins and Acting FDA Commissioner Kyle Diamantas. It takes immediate effect and runs for three years, subject to renewal, modification, or termination. In a press release, Chairman Atkins described FDA-related disclosures by public companies as having “a significant impact on our markets” and identified the FDA as “a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws.” Acting Commissioner Diamantas framed the MOU as protecting “both the patients who rely on FDA-regulated products, and the public trust that drives health care innovation.”

On September 11, 2026, the OCC, FDIC, Federal Reserve, and NCUA proposed to replace the 2023 Interagency Guidance on Third-Party Relationships with a shorter, principles-based document.1 Two companion releases complete the package: a final interagency statement on the supervision of the use of core service providers by community banks, effective on issuance,2 and a proposed Federal Reserve guide for traditional community banks (the Community Bank Guide).3 Comments are due November 16, 2026.4

California AB 1776 (Aguiar-Curry) — dubbed “The Competition and Opportunity in Markets for a Prosperous, Equitable and Transparent Economy (COMPETE) Act” — was signed into law by Governor Gavin Newsom, on September 30, 2026. The new law, which takes effect on January 1, 2027, bans single-firm monopolization, making it “unlawful for every person to monopolize or monopsonize, attempt to monopolize or monopsonize, maintain a monopoly or monopsony, or combine or conspire with another person to monopolize or monopsonize any part of trade or commerce.” Crowell & Moring served as counsel to the California Chamber of Commerce (CalChamber) throughout the legislative process, advising on the bill’s impact and advocating for critical amendments designed to preserve competition and innovation in California.

When an agency conducts a multiple-award indefinite delivery, indefinite quantity (IDIQ) competition, successful awardees often wonder whether they can protest the agency’s award to other companies at the U.S. Court of Federal Claims. For over a decade, the answer has been a murky “maybe” with various Court of Federal Claims decisions divided over the issue. But in a precedential September 16, 2026, decision, the U.S. Court of Appeals for the Federal Circuit in Island Creek Associates, LLC v. United States resolved this split, holding that IDIQ contract awardees lack standing to challenge the IDIQ awards to fellow competitors.

The rapid emergence of AI/ML tools in drug discovery, from target identification to generative molecular design, lead optimization, and repurposing, has transformed how life sciences companies build some of their most valuable assets. As AI/ML tools take on an increasingly significant role in the drug discovery process, companies face a set of largely unresolved IP challenges that require careful planning and proactive governance.  

The Centers for Medicare and Medicaid Services (CMS) will add four condition tracks to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model next spring, according to a September 15 announcement, to address gaps in chronic disease management between scheduled provider visits. The 10-year voluntary model officially launched on July 5, 2026. In its initial form, ACCESS targeted four high-prevalence conditions: high blood pressure, diabetes, chronic musculoskeletal pain, and depression. CMS reports that three out of four Medicare beneficiaries qualify for at least one existing ACCESS track. The new and expanded condition tracks are heart failure, chronic obstructive pulmonary disease (COPD), substance use disorders (SUDs), and tobacco cessation. In addition, the existing chronic musculoskeletal pain track, which is currently limited to an initial 12-month period, will be extended for certain specified conditions.  

As the January 1, 2027, employer contribution implementation date approaches, employers should be aware of Maryland’s FAMLI Program obligations. 

On September 1, 2026, the Eleventh Circuit issued its long-anticipated decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that the qui tam provisions of the False Claims Act are constitutional because relators are not officers of the United States who occupy continuing positions established by law. The decision overturned the 2024 district court ruling that sparked a wave of constitutional challenges to qui tam suits and aligns the Eleventh Circuit with the Fifth, Sixth, Ninth, and Tenth Circuits on the issue. The constitutional debate is far from over, however, as the decision is limited to the constitutionality under the Appointments Clause. The court remanded the case for further evaluation of the parties’ Take Care and Vesting Clause arguments. At the same time, similar constitutional arguments are pending in the Third Circuit, related to the largest-ever FCA judgment in a non-intervened case, and multiple Supreme Court justices have already signaled potential willingness to weigh in on the qui tam provisions’ constitutionality. Crowell's FCA attorneys explain these developments and what's next in a “Feature Comment” published in The Government Contractor.

On September 15, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a significant decision in East Fork Enterprises, Inc. v. EPA, vacating EPA’s 2024 methylene chloride risk management rule and the underlying revised unreasonable-risk determination under Section 6 of the Toxic Substances Control Act (TSCA). The court granted the industry petitioners’ challenge, denied Sierra Club’s petition, and remanded the matter to EPA.

The FTC notched a recent win in federal court, securing a permanent injunction halting the combination of the two dominant brands of construction adhesives, Loctite and Liquid Nails.  In the recently unsealed decision, the court focused on the extensive head-to-head competition between the parties and the importance of brand equity in siding with the FTC, offering important lessons for merging parties.   

The U.S. Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI) published its long-anticipated Guidance on Generative Artificial Intelligence in August. The guidance explains how generative AI (GenAI) use is evaluated under the revised research misconduct regulations (42 CFR Part 93), which took effect January 1, 2025, and became applicable to new allegations on January 1, 2026. The new guidance builds on prior guidance documents regarding the definitions of fabrication, falsification, and plagiarism, as well as revised evidentiary standards. As of April 30, 2026, institutions were required to have compliant policies on file with ORI as part of their annual report covering 2025. 

On September 21, 2026, the Small Business Administration announced an extension of the comment period for two previously proposed rules that, as currently constructed, would significantly expand the pool of entities eligible to qualify for small business set-aside procurements. The extension is slated to be formally published on September 24, 2026.  While the comment period was originally to close on September 21, in response to requests for additional time, SBA has extended the comment period for an additional 60 days with comments now due by November 20, 2026.

The UK government has launched a consultation that could fundamentally change the UK’s corporate reporting framework. The consultation was published on 7 September 2026 and closes on 30 November 2026. 

When federal law enforcement agencies issue subpoenas to companies for information about their customers, the subpoenas or cover letters often contain boilerplate nondisclosure language. This language generally directs companies not to notify those customers and implies that there may be legal consequences for doing so. But as two lawmakers recently called out in a formal letter to the U.S. Supreme Court and the U.S. Government Accountability Office (GAO), this boilerplate language may not carry the force of law.

In recent years, the U.S. federal government has taken significant interest in the cybersecurity compliance of its contractor base. In 2025 alone, the U.S. Department of Justice’s (DOJ) Civil Cyber-Fraud Initiative recovered more than $50 million across nine False Claims Act (FCA) cybersecurity fraud settlements, and it has secured almost 20 settlements since its launch in October 2021. Because most defendants facing FCA liability for alleged cybersecurity noncompliance enter into pre-litigation settlements, the last court decision in a cybersecurity FCA case was in 2022. However, earlier this month, on September 2, 2026, in  United States ex rel. Pannek v. Archer Daniels Midland Co., No. 23-cv-15145, 2026 WL 2593317 (N.D. Ill. Sept. 2, 2026), Judge Sunil R. Harjani of the U.S. District Court for the Northern District of Illinois granted a motion to dismiss on materiality grounds and offered additional guidance on what a plaintiff must allege to adequately state an FCA cybersecurity claim.

Part Two of a Two-Part Client Alert Series. This Alert builds on the discussion in Part One, which surveyed Bear Creek (2017), Copper Mesa (2016), South American Silver (2018), Eco Oro (2021), and Lupaka (2025).

September 2026 marks the first anniversary of the corporate criminal offence of failure to prevent fraud coming into force under section 199 of the Economic Crime and Corporate Transparency Act 2023 (ECCTA). The Home Office guidance recommends that organisations review their fraud prevention measures at least every 12 months.

New York Attorney General Letitia James has issued an industry-wide alert encouraging workers with knowledge of unsafe or illegal conduct at artificial intelligence (AI) companies to file confidential whistleblower complaints through the Office of the Attorney General’s (OAG) secure portal. This development signals a significant escalation in regulatory scrutiny of the AI sector and should be carefully considered by any company developing or deploying AI technology that has a nexus to New York.