PharmaDossierIndependent biopharma information, guidance, and source-cited analysis.

PHARMApharmadossier

Topic

CDMO

Contract development and manufacturing organizations, CDMO oversight, quality agreements, manufacturing site changes, and supply chain strategy.

6 articles·Lives underManufacturing Policy·Last updated 2026-07-21

Policy· July 21, 2026 · 17 min read

FDA Class I Medical Device Recalls by the Numbers (2026)

By Ran Chen#Combination Product #Drug Delivery Device #Supply Chain

Manufacturing· July 21, 2026 · 18 min read

Orthopedic & Spinal Implant GUDID UDI Landscape (2026)

By Ran Chen#Supply Chain #CDMO #BIOSECURE Act

Global· July 20, 2026 · 17 min read

FDA-registered device establishments by country (2026)

By Ran Chen#Supply Chain #China #BIOSECURE Act

Policy· July 18, 2026 · 18 min read

Drug-delivery device recalls: infusion pumps 3.4x more likely to be Class I

By Ran Chen#Drug Delivery Device #Combination Product #Supply Chain

Policy· June 8, 2026 · 11 min read

BIOSECURE Act and the API supply chain: DMF strategy for launch teams

By Ran Chen#BIOSECURE Act #API Manufacturing #Drug Master File

Global· June 8, 2026 · 11 min read

South Korea MFDS biosimilar reform 2026: what US launch teams need to know

By Ran Chen#Biosimilars #Regulatory #FDA Approval