Last month, the US Food and Drug Administration (FDA) issued a draft guidance explaining how it intends to implement the mandatory recall authority established under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The 2026 District of Columbia elections may be the most consequential elections since the advent of home rule in 1975. Against a backdrop of greater federal intervention into the city’s affairs, depleting federal resources, and local budget pressures, many of the city’s most important local offices will have new leadership after the elections in November.
Last month, a federal court in Maine halted the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program in its tracks — a mere four days before it was to go into effect.
A receivership is a court-supervised tool to stabilize operations of a distressed borrower, ring-fence pledged revenues, and drive recoveries for municipal bondholders when bankruptcy is not available or not desirable.
As we approach the end of the first year of the second Trump Administration, many in the health care sector continue to closely watch federal enforcement trends to identify government priorities going forward.
On December 22, 2025, the US Department of Justice (DOJ) sued Stanley Black & Decker in the US District Court for the District of Maryland, alleging violations of the Consumer Product Safety Act (CPSA).
Over the past year, both the executive branch and the courts sought to pare back certain stringent aspects of National Environmental Policy Act (NEPA) reviews. However, a decision issued in December 2025 illustrates that agencies cannot defer conducting NEPA-required reviews until after project approval.
For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.
A federal judge in the Central District of California recently denied a surf apparel brand’s request to halt sales of Lady Gaga’s Mayhem album merchandise.
On December 16, 2025, the US Securities and Exchange Commission’s (SEC) Division of Examinations released a risk alert, “Additional Observations Regarding Advisers’ Compliance with the Advisers Act Marketing Rule.”
The California Department of Public Health (CDPH) denied two petitions to amend the hospital licensing regulations in Title 22 of the California Code of Regulations to allow advanced practice providers to be members of organized medical staffs in general acute care hospitals.
For the first time in 26 years, the US Food and Drug Administration (FDA) has proposed adding a new active ingredient to the list of permissible sunscreen actives in the United States.
Anthony V. Lupo, Angela M. Santos, R. Erica Roque, George P. Angelich, Justin A. Kesselman, James E. Britton
The 2025 holiday retail shopping season is nearly a wrap. Consumers will be on the hunt for year-end discounts, and gift card purchases likely will surge over the coming days.
In this episode of Five Questions, Five Answers, Birgit Matthiesen and Jessica DiPietro explore the historical context and implications of the Nixon Shock and the Trade Expansion Act, focusing on Section 232 investigations and their impact on US trade policy.
Linda M. Jackson, Matthew F. Prewitt, Allan E. Anderson, Nicholas J. Nesgos, Alexander H. Spiegler, Meghan F. Hart, John M. Hindley, Nicole Curtis Martinez
A magistrate judge of the US District Court for the District of Delaware issued a report and recommendation recommending the denial of the defendants’ Rule 12(b)(6) motion to dismiss SambaSafety’s Defend Trade Secrets Act (DTSA) claim arising from alleged misappropriation of driver compliance software and related data systems.
The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a 10‑year voluntary payment model that introduces outcome‑aligned payments (OAPs) to expand access to technology‑supported care for Medicare beneficiaries with common chronic conditions.
On December 18, President Trump issued an executive order (EO) directing the Attorney General to complete rulemaking to reschedule “marijuana” from Schedule I to Schedule III under the Controlled Substances Act (CSA) and to expand federal research and policy development on medical marijuana and hemp derived cannabinoids.
Danielle W. Bulger, Thorne Maginnis, Michelle A. Cooke, Amy (Salomon) McFarland, Sarah Alberstein, Natasha Weis
The use of artificial intelligence (AI) to generate digital representations of real or fictional people — “AI avatars” — offers new ways to build brands, drive engagement, and grow revenue by accelerating content creation and lowering production costs. It also raises the following important legal considerations.
On December 19, New York Governor Kathy Hochul vetoed S8432/A8662, a bill to amend the New York LLC Transparency Act that would have decoupled it from the federal Corporate Transparency Act (CTA) definitions.
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Rebekkah R.N. Stoeckler, Apeksha Vora
Headlines that Matter for Companies and Executives in Regulated Industries
Many foreign nationals travel home during the holidays to visit family. Recent federal actions have significantly restricted international travel for some foreign nationals, creating a risk that some individuals could be stranded outside the United States for extended periods. These disruptions can affect both the individual and their US employer.
The past year has been unusually active on the health care antitrust front. Providers are pressing price-fixing and information-exchange theories against payers and claims intermediaries and a landmark class settlement moving into its implementation phase.
The US state-level privacy law landscape continues to evolve at a very rapid rate. On January 1, 2026, new state privacy laws take effect in Indiana, Kentucky, and Rhode Island. Cure periods sunset throughout the year for state privacy laws in Connecticut, Delaware, Kentucky, Minnesota, and Montana, with additional large language model (LLM) disclosure changes also effective this summer.
Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.
Adopting an “AI policy” is critical for managing an organization’s use of artificial intelligence (AI) tools. A targeted AI policy can provide clear guardrails that can then be incorporated into organization-wide training but be prepared to pivot quickly as these technologies evolve.