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
CMC
Chemistry, manufacturing, and controls, including regulatory submissions, post-approval changes, established conditions, and global lifecycle management.
Manufacturing· August 24, 2026 · 17 min read
FDA's ACTIMP Potency Guidance: Personalized Peptide and Neoantigen Lot Release
By Ran Chen#CMC#Manufacturing Capacity#Pipeline
Manufacturing· May 22, 2026 · 10 min read
Analytical Method Transfer Acceptance Criteria for a New Release-Testing Lab
By Ran Chen#CMC#FDA#Regulatory
Manufacturing· May 22, 2026 · 13 min read
API supplier change control: DMF letter-of-authorization and notification traps
Manufacturing· May 22, 2026 · 10 min read
CDMO quality agreement red flags that become FDA inspection findings
By Ran Chen#Manufacturing Capacity#CMC#FDA Approval
Manufacturing· May 22, 2026 · 14 min read
CMC-only complete response letters: how commercial teams should read the risk
By Ran Chen#Manufacturing Capacity#CMC#FDA Approval
Manufacturing· May 22, 2026 · 12 min read
eCTD Module 3 lifecycle hygiene after multiple post-approval supplements
By Ran Chen#CMC#Post-Approval Changes#ICH
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
Manufacturing· May 22, 2026 · 14 min read
ICH Q12 established conditions in regulatory submissions
By Ran Chen#CMC#ICH#Regulatory
Manufacturing· May 22, 2026 · 11 min read