North America: Food, Drugs, Healthcare, Life Sciences

As pharmaceutical manufacturers increasingly adopt direct-to-patient programs to enhance access and affordability, they face a complex web of compliance challenges that evolve faster than regulatory guidance can keep pace. This analysis explores the critical legal and regulatory considerations—from Anti-Kickback Statute risks to state telehealth requirements—that companies must navigate when implementing DTP models. The authors propose a "compliance-by-design" framework that enables manufacturer

More than a year after U.S. Department of Health and Human Services (HHS) Secretary Kennedy directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to overhaul its longstanding regulations...

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.

Florida's Attorney General has launched an antitrust investigation into CVS Health and its pharmacy benefit manager Caremark, examining whether the company inappropriately steered patients to CVS pharmacies and reimbursed them at higher rates than independent pharmacies. The investigation, part of a broader multi-state scrutiny of PBM business practices, seeks documents and testimony on policies related to transparency, reimbursement rates, audits, and market concentration in an industry where three PBMs co

As pharmaceutical manufacturers increasingly adopt direct-to-patient programs to enhance access and affordability, they face a complex web of compliance challenges that evolve faster than regulatory guidance can keep pace. This analysis explores the critical legal and regulatory considerations—from Anti-Kickback Statute risks to state telehealth requirements—that companies must navigate when implementing DTP models. The authors propose a "compliance-by-design" framework that enables manufacturer

The Centers for Medicare & Medicaid Services has released comprehensive guidance on Applied Behavior Analysis services for autism spectrum disorder, signaling a major shift in federal oversight amid concerns over rapid spending growth and fraud. How will this 174-page toolkit reshape state Medicaid programs, provider requirements, and the future of ABA services across the country?

As global energy demand rises and pressure to decarbonise intensifies, biotechnology is emerging as a key driver of sustainable fuel innovation. This insight explores how advances in plant, microbial and algal biotechnology can support the transition to cleaner energy systems and contribute towards meeting United Nations Sustainable Development Goal 7.

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.

Fresenius Kabi and Dr. Reddy's Laboratories have received FDA approval for a rituximab biosimilar, marking another entry into the competitive market for alternatives to Genentech's RITUXAN. The approval, supported by comprehensive analytical, non-clinical, and clinical data, positions this biosimilar alongside three other FDA-approved rituximab alternatives already on the market.