Blogs

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

In a decision earlier this year, the US Supreme Court held that plaintiffs bringing civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims may be able to recover damages for business or property losses that stem from personal injuries.

On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments.

On June 11, the US Department of Commerce, Bureau of Industry and Security (BIS) announced the release of two General Authorizations, accompanied by additional Frequently Asked Questions (FAQs) related to the January 16 Information and Communication Technology and Services (ICTS) Rule that prohibits the import and sale of connected vehicles and their related hardware/software with a sufficient Chinese or Russian nexus, “Securing the Information and Communications Technology and Services Supply Chain: Connected Vehicles” (the Connected Vehicles Rule).

In one of the first substantive decisions analyzing whether the use of copyrighted works to train large language models (LLMs) for generative artificial intelligence (AI) services is infringing or a fair use, Judge William Alsup issued a split decision in his summary judgment order. See Bartz et al. v. Anthropic PBC, No. 3:24-cv-05417 (N.D. Cal. Aug 19, 2024).

The District of Columbia is set to implement sweeping changes to its DC Health Care Alliance, a program that has provided vital health coverage to low-income residents who do not qualify for Medicaid or Medicare, including many non-citizens, since its inception in 2001.

Headlines that Matter for Companies and Executives in Regulated Industries

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations (MSOs).

District of Columbia Mayor Muriel Bowser’s FY 2026 Budget introduces a new Basic Health Program (BHP) that will fundamentally reshape health coverage options for thousands of District residents beginning next calendar year.

For decades, California has been granted unique deference in setting Clean Air Act (CAA) emissions limitations for California-sold vehicles through use of a state-specific waiver.

Indemnification and advancement clauses are often seen as mere boilerplate language in a company’s governing documents, routinely copied from one form agreement to another. However, advancement clauses may be important sources of leverage in ownership disputes and business divorce cases, potentially impacting the outcome more than the merits of the claims.

Changes in presidential Administration often mean changes in policy priorities and budgeting, but a Maryland federal district court recently held that the executive branch’s ability to pivot on policy has limits.

Congress enacted the No Surprises Act (NSA) to protect patients from unexpected medical bills. A central pillar of the NSA is its independent dispute resolution (IDR) process, under which payers and providers can submit disputed claims to binding arbitration.

On June 4, the US Securities and Exchange Commission (SEC) published a concept release soliciting public comment on potential amendments to the definition of foreign private issuer (FPI) under US securities laws.

Strategic protection of intellectual property (IP) is crucial for driving the growth and sustainability of high-tech startups, enabling them to secure their innovations, maintain a competitive edge, and strengthen their market position.

US Supreme Court Clean Air Act (CAA) decisions often result in big-picture changes to administrative law. Two CAA decisions this term deal with CAA’s venue-related provisions which specify where cases challenging US Environmental Protection Administration (EPA) determinations can be filed.

The National Environmental Policy Act (NEPA) is a federal statute that outlines how federal agencies must review the environmental impacts of their regulatory actions. The regulated community has often viewed NEPA as an obstacle to a broad range of federal actions in areas ranging from energy permitting to agriculture.

Fresh tensions are rising between creative expression and intellectual property rights.

The US Patent and Trademark Office (USPTO) recently issued a Director Discretionary Denial decision expanding on the “settled expectations” ground for discretionary denial of a post-grant review proceeding.

The Walt Disney Company and Universal City Studios Productions are among the latest plaintiffs to bring a lawsuit against an artificial intelligence (AI) developer.

As of mid-2025, private equity (PE) investors remain intensely interested in health care services and technology companies despite higher borrowing costs, heightened regulatory scrutiny, and an increasingly complex state review landscape.

The Federal Circuit recently clarified in Ingenico Inc. v. IOENGINE, LLC that inter partes review (IPR) estoppel does not extend to physical systems described in prior art patents or printed publications.

Welcome to the June 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

Running a college has never been an easy job. But as this academic year draws to a close, higher education is experiencing new challenges with potential long-lasting impacts.

Headlines that Matter for Companies and Executives in Regulated Industries