urning the corner on 2026’s first calendar quarter presents a good opportunity to revisit the top ten, most-read Global Forum articles from 2025. Here’s what you read the most:
Cannabis-Derived Drugs in Japan: New Legislation and Outlook
Developing Drugs for Rare Diseases: A New Approach to Generating Clinical Evidence
Invitation to Comment: Warp-Speeding Regulatory Decisions
Accelerated Approval as the New “Norm” in Gene Therapy for Rare Diseases
China’s New Drug Approvals Again Hit Record High in 2024
Patients Need Not Wait: Evolving Compassionate Use and Named Patient Programs Across Asia Pacific
eCTD v4.0: A Look at 2025 and Beyond
Therapeutic Innovation & Regulatory Science (TIRS) Top Ten from 2025
If you’d like to learn more about these and other topics covered in Global Forum, here are 2025’s top ten most-read articles* from DIA’s official peer-reviewed, scientific journal, Therapeutic Innovation & Regulatory Science.
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data (open access)
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today? (open access)
Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance (open access)
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials (open access)
Reliance into Action: Understanding EMA Documents to Streamline Reliance for Marketing Authorization Applications (open access)
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation (open access)
The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments (open access)
*Published 2023 – 2025.