RWE & Cross-Border Data: Accelerating Oncology Approvals with ICH E6(R3)
{
"content": "Real-world evidence (RWE) and cross-border data are transforming oncology development. Sponsors aiming for accelerated approvals must balance scientific rigor with regulatory expectations across jurisdictions, and the new ICH E6(R3) framework offers a timely scaffold. This post ex...
Robert Maxwell
Oct 30, 2025
Breast cancer approvals
Obesity pharmacotherapy trials
Pediatric hypospadias devices
Influenza vaccine regulation
