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, the European Commission proposed a new Public Procurement Act that would fundamentally change the way that public procurement is regulated across the EU. In this alert we look at what changes have been proposed, and discuss how those changes would affect companies – whether EU-based or not — that wish to participate in European public procurement.  

Last week during the National Advertising Division 2026 Annual Conference, the Federal Trade Commission (FTC) provided insights on its enforcement priorities, and the National Advertising Division (NAD) provided updates on recent cases and procedural updates. 

On September 30, 2026, California Governor Gavin Newsom signed Senate Bill 947, the “No Robo Bosses Act,” into law, effective July 1, 2027. The law prohibits California employers from relying solely on AI or other automated decision systems (ADS) to discipline or terminate employees, and requires meaningful human review and written notice to affected workers when such tools play a primary role in those decisions. Employers using AI-driven workforce management tools should begin compliance planning now.

On October 1, 2026, the U.S. Department of Justice’s (DOJ) National Fraud Enforcement Division issued Directive 26-12: Corporate Enforcement in the Fight Against Fraud. Assistant Attorney General Colin M. McDonald’s October directive follows his August 2026 memorandum setting the Division’s enforcement priorities. The directive signals — in the DOJ’s words — “an aggressive, all-tools” enforcement posture across the Division’s health care, government contracting, tax, and trade fraud priorities, while simultaneously supporting the incentives designed to promote transparency, reward cooperation, and encourage voluntary disclosure of misconduct. 

In recent years, there has been a wave of new legislation impacting contracts and contractual terms. The Belgian legislator is gradually adopting the different Books of the Belgian Civil Code, and the Belgian Code of Economic Law has been updated several times. These changes affect the way contract terms need to be drafted, not only between companies but also with consumers. 

 On September 28, 2026, the U.S. District Court for the Middle District of Florida upheld the U.S. Centers for Medicare and Medicaid Services’ (CMS) final rule governing organ procurement organizations (OPO). The rule, promulgated in 2020, will have its fullest effect when CMS releases final OPO performance rankings determining the fate of the 55 OPOs (Regulatory Uncertainty Ahead For Organ Transplant System). The Middle District of Florida is among five courts hearing challenges to the rule and the first to issue a decision. Legacy of Life Hawaii v. HHS, which was filed August 6, 2026, is the most recent.  

The U.S. Food and Drug Administration (FDA) proposed a change to the Generally Recognized as Safe (GRAS) notification system for the first time in almost 30 years. The new proposed rule, unlike the current rule proposed in 1997 and finalized in 2016, makes GRAS notifications mandatory. The comment period for the proposed rule ends in only two months (December 9, 2026), and stakeholders should act promptly to submit comments before the deadline closes. Given the significance of the proposed changes for food manufacturers and suppliers, understanding the scope and implications of the rule is critical now — before it is finalized.

California Assembly Bill 1603 amends the Food and Agricultural Code by directing DPR to take several concrete steps no later than January 1, 2028 to identify and disclose PFAS pesticide ingredients in California-registered pesticides.  DPR must now flag whether each registered pesticide contains PFAS pesticide ingredients in its online pesticide use reporting database, designate PFAS as a searchable category of interest within that database, and incorporate PFAS pesticide use trends into its annual pesticide use report and related reporting documents on an ongoing basis. Separately, DPR must compile and publish on its website a complete list of all registered pesticides containing PFAS pesticide ingredients and deliver that list to every county agricultural commissioner in California. After the initial publication, DPR is required to update the list and redistribute it to all county commissioners within 60 calendar days whenever a new PFAS-containing pesticide is registered.  

On September 28, 2026, the General Services Administration (GSA) issued a new clause for incorporation into government contracts of artificial intelligence systems, 552.239-7001, Basic Safeguarding of Data within Large Language Model Artificial Intelligence Systems, as a GSA Regulation Deviation (the Final Clause). The Final Clause will become effective on October 19, 2026.

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.