Specialty· August 30, 2026 · 23 min read
Topic
Drug Delivery Device
Prefilled syringes, autoinjectors, on-body injectors, wearable delivery systems, and drug-device combination product development.
Biosimilars· August 17, 2026 · 18 min read
FDA Biosimilar Device Guidance: Presentations That Are Not Interchangeable
By Ran Chen#Biosimilars#Interchangeability#Purple Book
Specialty· August 9, 2026 · 20 min read
Aesthetic Procedure Adverse Events by the Numbers (2026)
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)
Policy· July 21, 2026 · 17 min read
FDA Class I Medical Device Recalls by the Numbers (2026)
Manufacturing· July 20, 2026 · 20 min read
FDA device clearances & approvals by the numbers (2026)
Policy· July 18, 2026 · 18 min read
Drug-delivery device recalls: infusion pumps 3.4x more likely to be Class I
Manufacturing· July 18, 2026 · 20 min read
MAUDE drug-delivery adverse events: insulin pumps dominate 1.39M reports
Pricing & Access· July 18, 2026 · 18 min read
Sarclisa Escena SC access: CirCLIQ on-body injector, trial data, and billing
By Ran Chen#Oncology#FDA Approval#Specialty Pharmacy