Manufacturing· August 25, 2026 · 15 min read
FDA's 2026 CCS Draft Replaces 1999 Packaging Guidance, Not Biosimilar Devices
By Ran Chen#CMC#Manufacturing#Combination Product
Topic
Combination Product
FDA drug-device and biologic-device combination products, PMOA classification, center assignment, and regulatory pathway guidance.
Biosimilars· August 17, 2026 · 18 min read
FDA Biosimilar Device Guidance: Presentations That Are Not Interchangeable
By Ran Chen#Biosimilars#Interchangeability#Purple Book
Manufacturing· July 24, 2026 · 17 min read
FDA AI/ML-Enabled Medical Devices by the Numbers (2026): 1,451 Cleared and Counting
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
Approvals· July 16, 2026 · 22 min read
Human factors validation: May 2026 FDA guidance & launch critical path
Approvals· June 8, 2026 · 9 min read