Summary and Key Takeaways from FDA’s September 2026 Public Hearing on Psychedelic Drugs
On September 14, 2026, FDA convened a Part 15 hearing to discuss “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” The meeting was a compilation of 2 minute segments for 80 public commentators representing a diverse community of academia, patients, advocates, service providers, and industry.
The Physician Layer: Why Medical Oversight in PV is Non-Negotiable
Yes, automation can process volume. What it can’t do is exercise clinical judgment on a case that doesn’t fit the pattern, defend a causality assessment to a health authority inspector, or carry a program’s institutional history from one reviewer to the next. Those are not workflow steps. They’re physician functions.
Best Practices in Oncology Joint Clinical Assessment (JCA) Submissions Under the EU HTA Regulation
The first oncology JCA reports show that this new EU assessment process is anything but routine. Here’s what sponsors can learn from early submissions, and how to prepare for what’s ahead.
AI and Automation in Patient Services: A Strategic Guide to Using the Right Tool
The question for Patient Services leaders isn’t automation vs. AI. It’s knowing where each capability creates value, where it introduces risk, and how to build both into a stronger service model.
Patient Access in 2026: What’s Changing, and Why it Matters
The story of patient access this year is really two stories that meet in the same place. The first is structural: the insurance landscape is being rebuilt, reshaping how pharmacy benefits are paid for, how long people keep coverage, and what a marketplace plan covers. The second is where patients feel it.
Real-World Evidence in EU Joint Clinical Assessments: Strategic Use and Methodological Standards
With immature survival data, single-arm trials, and limited comparators common in early JCA submissions, real-world evidence is becoming a strategic necessity, not an afterthought. Learn how sponsors can plan and generate RWE that meets the methodological bar EU assessors expect.
From Approval to Access: Adopting a “One Evidence Package” Mindset for Success in the EU Joint Clinical Assessment Era
The EU Joint Clinical Assessment is driving a new approach to evidence generation, where regulatory approval and market access considerations must be addressed together. Drawing on lessons from the first completed and discontinued JCA cases, this article explores how integrated evidence planning, comparative effectiveness evidence, proactive PICO management, and strategic use of real-world evidence can help organizations navigate evolving European requirements and support successful reimbursement and patient access outcomes.
Navigating the AI Landscape: Expanding the Toolbox (Part 2) and Having a Little Fun Along the Way
AI can support much more than drafting content. In Part 2 of our series, we explore practical tools that help teams organize information, improve communication, capture meeting insights, visualize complex concepts, and work more efficiently so experts can stay focused on what matters most.
Why 95% Compliance Isn’t Enough: The Hidden Cost of That 4–5% Gap
A 95% compliance rate sounds strong, until you calculate what it means at 100,000 cases a year. Here’s what’s actually hiding in that gap, and the four questions every sponsor should ask before signing with a PV vendor.
