United States: Food and Drugs Law

The FDA, in collaboration with federal partners, held a landmark public hearing on September 14, 2026, to gather input on the future therapeutic use of psychedelic drugs, drawing over 18,000 registered attendees. This hearing represents one of the earliest implementations of Executive Order 14401, which directs federal agencies to expedite research, review, and approval of psychedelic drugs for serious mental health conditions.

InvaGen Pharmaceuticals Inc., a Cipla Limited subsidiary, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck's KEYTRUDA® (pembrolizumab), in the United States. This collaboration represents the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates, with Qilu handling development and regulatory registration while Cipla USA manages commercialization.

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.

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.”

On September 1, 2026, the Food & Drug Administration (FDA) reinforced its prior conclusion that fluoropolymers used in medical devices are safe and materially different from the per- and polyfluoroalkyl substances (PFAS) that drive most regulatory, litigation and public health concerns

Benesch's Dialysis & Nephrology Digest provides monthly updates on the dialysis and nephrology industry, covering ASC policy changes, Medicare payment reforms, AI regulations in healthcare, kidney care innovations, and practice management developments. This August 2026 edition highlights major shifts in outpatient care, anesthesia staffing models, prior authorization reforms, and emerging kidney therapies.

The USDA's Animal and Plant Health Inspection Service is reviewing a petition for genetically engineered European plum lines designed to promote early and near-continuous blooming. APHIS has prepared a draft plant pest risk assessment concluding these modified plums are unlikely to pose increased plant pest risks compared to nonmodified varieties, with public comments due by October 13, 2026.

The U.S. Department of Health and Human Services-Office of Inspector General issued a favorable advisory opinion on an independent charity patient assistance program funded by pharmaceutical manufacturers, outlining critical safeguards to minimize fraud and abuse risks while ensuring compliance with the Anti-Kickback Statute.