United States: Healthcare

As of July 1, 2026, California is the first state in the United States to mandate that large restaurant chains disclose major food allergens directly on their menus.

The Centers for Medicare and Medicaid Services has issued a Final Rule prohibiting federal Medicaid and CHIP reimbursement for certain gender-affirming healthcare treatments for minors, including puberty blockers, cross-sex hormone therapy, and surgical interventions. The purpose-based restriction creates exceptions for the same treatments when used for other medical purposes, while maintaining coverage for mental health counseling and medically verifiable disorders of sexual development.

The U.S. Department of Justice announced a landmark $46 million settlement with Veloxis Pharmaceuticals for allegedly paying healthcare professionals kickbacks through lavish meals, luxury trips, and sham consulting arrangements to induce prescriptions of its kidney transplant drug. The resolution includes criminal penalties, civil settlements, and a record-breaking $1.55 million penalty for Sunshine Act violations, marking the largest such recovery since the law's passage in 2010. This case demonstrates DO

For global medical device manufacturers, regulatory submissions often contain information created in multiple languages, formats, and locations. When that information must be submitted to the U.S. Food and Drug Administration (FDA), translation becomes more than a language exercise.

The FDA has announced a September 2026 public hearing to gather stakeholder feedback on the therapeutic use of psychedelic drugs in supervised settings, marking a significant federal policy shift following the Trump administration's Executive Order directing agencies to accelerate psychedelic drug research and approval. This development, coupled with newly released FDA guidance on clinical investigations, signals an evolving regulatory landscape that extends beyond traditional drug approval pathways into cl

On July 31, 2026, the Health Resources and Services Administration (HRSA) announced a revised 340B Rebate Model Pilot Program. The proposal would allow qualifying manufacturers to provide the 340B ceiling price for certain drugs through a post-purchase rebate rather than the upfront discount that has long been the norm in the 340B Program.

For the first time in California’s history, hospice agencies have become subject to comprehensive hospice-specific licensing regulations adopted on an emergency basis...

On August 10, 2026, the U.S. Department of Health and Human Services ("HHS") announced the Food and Drug Administration's ("FDA") proposed new rule to change the way food substances are regulated.

The Department of Health and Human Services has unveiled Operation TrialBlazer, a comprehensive initiative to accelerate US-based clinical research and maintain American competitiveness in early-stage drug development. Meanwhile, FDA continues to shape the regulatory landscape through new guidance on psychedelic therapies, authorization pathways for generative AI medical devices, and planned rulemaking that could fundamentally alter prescription drug advertising requirements.