Food, Drugs, Healthcare, Life Sciences

Global pharmaceutical and medical device companies face hidden translation risks in FDA submissions that go beyond linguistic accuracy. Untranslated embedded content, inconsistent terminology across documents, version control gaps, and regional language differences can create regulatory delays even when translations appear complete.

The expansion of MFN pricing could have downstream consequences for acquisition costs, reimbursement methodologies, manufacturer contracting, patient access and pharmacy economics.

The USDA's Animal and Plant Health Inspection Service has determined that genetically engineered American Chestnut trees, developed for enhanced tolerance to chestnut blight fungus, no longer require regulatory oversight. This landmark decision follows extensive evaluation of scientific data, public comments, and plant pest risk assessments submitted by the State University of New York College of Environmental Science and Forestry.

Global pharmaceutical and medical device companies face hidden translation risks in FDA submissions that go beyond linguistic accuracy. Untranslated embedded content, inconsistent terminology across documents, version control gaps, and regional language differences can create regulatory delays even when translations appear complete.

The expansion of MFN pricing could have downstream consequences for acquisition costs, reimbursement methodologies, manufacturer contracting, patient access and pharmacy economics.

On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) signed a Memorandum of Understanding (the “MOU”)[1] to “establish a framework to support the parties’ respective regulatory and enforcement responsibilities and otherwise enhance cooperation.”

The Ninth Circuit's landmark decision in Adventist Health System v. AbbVie Inc. has opened a new front in healthcare fraud enforcement by allowing 340B covered entities to bring False Claims Act qui tam suits against drug manufacturers over alleged pricing violations. This ruling, combined with the court's earlier EKRA decision in Schena, signals an expanding landscape of federal healthcare fraud theories that narrows traditional defenses and creates significant litigation exposure for pharmaceutical compan

State legislatures and regulatory bodies are reshaping the telehealth landscape through new laws addressing reimbursement parity, remote patient monitoring coverage, controlled substance prescribing, and clinical supervision standards. These July developments reveal how policymakers are balancing expanded access to virtual care with targeted safeguards and compliance requirements that affect healthcare providers, digital health companies, and technology platforms across multiple jurisdictions.

The U.S. Food and Drug Administration is developing a novel regulatory framework for generative AI-enabled medical devices that would evaluate these products similarly to how physicians are credentialed. The agency proposes a two-axis risk assessment model and emphasizes post-market monitoring to address the unique challenges posed by AI systems that can produce variable outputs and evolve over time.