Manufacturing· September 8, 2026 · 23 min read
Topic
Regulatory Affairs
Global regulatory strategy, EMA Centralised Procedures, FDA review pathways, PDUFA preview tracking, and regulatory dossier assembly.
Policy· September 7, 2026 · 34 min read
EClinCloud AI-Assisted Study Build: What Sponsors Must Accept Before EDC Go-Live
By Ran Chen#FDA#Regulatory#Clinical Trials
Manufacturing· September 7, 2026 · 28 min read
PreCheck's Type V Facility DMF Is Not a PAI, and a CDMO Seat Does Not Transfer CGMP
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Manufacturing· September 6, 2026 · 30 min read
Annex 1 CCS Is Not FDA's 2026 Packaging CCS, and Neither Replaces 2004 Aseptic Guidance
By Ran Chen#Manufacturing Capacity#Manufacturing#CMC
Policy· August 24, 2026 · 18 min read
FDA's Expedited IND Pilot: 30-Day Safe-to-Proceed Clock and QRI Review
By Ran Chen#FDA Approval#Clinical Evidence#Pipeline
Policy· August 21, 2026 · 19 min read
Reject China Trial Data Without Audits: What the Moolenaar Letter Would Do
By Ran Chen#Clinical Trials#Regulatory#China
Policy· August 9, 2026 · 18 min read
340B Rebate-Model Ruling: D.C. Circuit Puts HHS in the Driver's Seat (2026)
By Ran Chen#340B#Drug Pricing#Payer Policy
Policy· August 8, 2026 · 14 min read