Policy· August 8, 2026 · 14 min read
Topic
EMA
European Medicines Agency decisions, CHMP opinions, EU regulatory strategy, and global launch implications.
Policy· August 7, 2026 · 14 min read
EUDAMED mandatory 2026: EU device database scale, actors, and MDR deadlines
By Ran Chen#Policy#Regulatory#Supply Chain
Policy· August 2, 2026 · 29 min read
EU Clinical Trials by the Numbers 2026: 12,123 CTIS Records Analyzed
By Ran Chen#Clinical Trials#EMA#Clinical Evidence
Global· July 24, 2026 · 17 min read
EU vs US Biosimilars by the Numbers (2026): An EMA and FDA Purple Book Registry Comparison
By Ran Chen#Biosimilars#EMA#FDA Approval
Policy· July 16, 2026 · 24 min read
Companion diagnostic change control: FDA PMA supplement vs. EU IVDR
By Ran Chen#Companion Diagnostic#FDA Approval#EMA
Pipeline· July 16, 2026 · 22 min read
Digital health endpoints in FDA trials and the payer handoff gap
By Ran Chen#Clinical Trials#Payer Policy#FDA
Manufacturing· May 22, 2026 · 12 min read
Global CMC change classification mismatch between FDA, EMA, and non-ICH markets
By Ran Chen#CMC#Post-Approval Changes#ICH