Jonathan Trinh ([email protected])
2 articles on News & Perspectives | Arnold & Porter
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FDA Proposes Revised Payor Communications Draft Guidance to Formally Include Devices and Reflect New Statutory Safe Harbor While Balancing Substantial Government Interests
The U.S. Food and Drug Administration’s 2026 Draft Payor Guidance would update the framework for communications between drug and device manufacturers and payors, including guidance on healthcare economic information, pre-approval communications, and information about unapproved uses of approved or cleared medical products. The draft guidance reflects recent
FDA Issues Revised Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products
On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States. As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and lat