Approvals· September 5, 2026 · 29 min read
Topic
Postmarketing Requirements
Postmarketing requirements and commitments, confirmatory evidence, safety monitoring, and lifecycle risk.
Approvals· September 4, 2026 · 36 min read
Lirafugratinib's Sept 27 PDUFA Does Not Rewrite Pemazyre PAs or Lytgobi CDx
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Policy· August 14, 2026 · 18 min read
FDA AEMS Explained: FAERS Replacement, Dashboard, & Safety Pipelines
By Ran Chen#Policy#FDA Approval#Clinical Evidence
Manufacturing· August 1, 2026 · 20 min read
FDA Warning Letters by the Numbers (2026): CDER Drug Enforcement Surge
Evidence· July 14, 2026 · 17 min read
H1 Antihistamines in FAERS: 925,032 Adverse-Event Reports
Evidence· July 13, 2026 · 16 min read
ADHD Medications in FAERS: 194,052 Adverse-Event Reports by the Numbers
Evidence· July 10, 2026 · 17 min read
Anticoagulant Adverse Events in FAERS: 244,000 Reports and Bleeding/HIT Profiles
Evidence· July 10, 2026 · 17 min read
Calcineurin Inhibitor Adverse Events in FAERS: 275,000 Reports and Key Safety Signals
Evidence· July 8, 2026 · 23 min read
Diuretic Adverse Events in FAERS: 763,000 Reports Across Three Sub-Classes
Evidence· July 8, 2026 · 28 min read