Manufacturing· August 7, 2026 · 18 min read
AI Dossier Governance Checklist: What DJ Fang's Benchmark Means for eCTD Teams
By Ran Chen#FDA Approval#Policy#Manufacturing
Section
Manufacturing
Capacity, CDMO strategy, inspections, supply bottlenecks, and manufacturing constraints that shape commercial reality.
28 articles · Last updated
Manufacturing· August 5, 2026 · 21 min read
2026 oncology injectable shortage: ifosfamide, carboplatin & buy-and-bill
By Ran Chen#Supply Chain#Oncology#Manufacturing
Manufacturing· August 1, 2026 · 20 min read
FDA Warning Letters by the Numbers (2026): CDER Drug Enforcement Surge
Manufacturing· July 26, 2026 · 17 min read
FDA Drug Shortages by the Numbers: 2026 National Registry Analysis
Manufacturing· July 24, 2026 · 17 min read
FDA AI/ML-Enabled Medical Devices by the Numbers (2026): 1,451 Cleared and Counting
Manufacturing· July 23, 2026 · 20 min read
Diabetes Device UDI Landscape by Manufacturer (2026)
Manufacturing· July 21, 2026 · 18 min read
Orthopedic & Spinal Implant GUDID UDI Landscape (2026)
By Ran Chen#Supply Chain#CDMO#BIOSECURE Act
Manufacturing· July 20, 2026 · 20 min read
FDA device clearances & approvals by the numbers (2026)
Manufacturing· July 18, 2026 · 20 min read
MAUDE drug-delivery adverse events: insulin pumps dominate 1.39M reports
Manufacturing· July 15, 2026 · 23 min read