Policy· August 19, 2026 · 18 min read
CMS Bona Fide Marketing Rule: What the D.C. Circuit Teva Ruling Actually Revived
By Ran Chen#Policy#IRA Negotiation#Medicare Part D
Topic
Generics
ANDA strategy, Paragraph IV risk, therapeutic equivalence, supply concentration, and price erosion.
Generics· August 18, 2026 · 14 min read
Generic Wakix Approved but Cannot Launch Until 2030: The Orange Book Fence
By Ran Chen#Orange Book#Generics#Generic Entry
Pricing & Access· August 16, 2026 · 18 min read
Hepatitis C Treatment Access in 2026: Generic Economics, PA, and Sobriety
Manufacturing· July 26, 2026 · 17 min read
FDA Drug Shortages by the Numbers: 2026 National Registry Analysis
Generics· July 25, 2026 · 21 min read
FDA Green Book by the Numbers (2026): 2,882 Approved Animal Drugs, Zoetis Leads
By Ran Chen#FDA Approval#Generics#NADA
Generics· July 15, 2026 · 29 min read
2026–2027 Generic Launch Scorecard: Which Patent Cliffs Are Worth Filing
By Ran Chen#Orange Book#Generic Entry#ANDA Approval
Manufacturing· July 15, 2026 · 23 min read
Sterile-Injectable Shortage Ledger: Capacity, Not Another ANDA, Is the Opening
Evidence· July 5, 2026 · 17 min read
Corticosteroid adverse events by the numbers: a 1.3-million-report FAERS analysis
Evidence· July 4, 2026 · 16 min read
Bisphosphonates in FAERS: 191,890 adverse-event reports by the numbers
Policy· June 30, 2026 · 18 min read
FDA Market Exclusivity by the Numbers: Exclusivity and GAIN Registry Analysis
By Ran Chen#Orange Book#Generics#Generic Entry