Policy· June 30, 2026 · 18 min read
China Drug Trial Data Protection (NMPA 2026 No.47): Exclusivity and BD Strategy
By Ran Chen#China#NMPA#Regulatory
Section
Policy
CMS, FDA, HHS, Federal Register, and payer-policy moves that change the rules under commercial teams.
27 articles · Last updated
Policy· June 30, 2026 · 18 min read
China's 2026 Medical Representative Measures: Building a Compliant Model
By Ran Chen#China#NMPA#Market Access
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
Policy· June 30, 2026 · 17 min read
IRA Medicare Drug Negotiation Proposed Rule: Market-Access Analysis
By Ran Chen#IRA Negotiation#CMS#Market Access
Policy· June 28, 2026 · 19 min read
How to Read an FDA REMS: ETASU, Shared vs. Single REMS, and the Patent Dance
By Ran Chen#REMS#Generics#FDA Approval
Policy· June 28, 2026 · 17 min read
Medicaid Drug Rebate Program Explained: AMP, Best Price, and the CPI Penalty
By Ran Chen#Medicaid#Drug Pricing#Payer Policy
Policy· June 21, 2026 · 5 min read
Building the AMCP dossier: a guide to the version 5.0 format and value evidence template
Policy· June 21, 2026 · 7 min read
JAK Inhibitor Safety Labels: FDA Boxed Warnings vs EMA PRAC Restrictions
By Ran Chen#FDA Approval#Payer Policy#Label Warnings
Policy· June 21, 2026 · 7 min read
Sitagliptin's May 2026 Generic Launch and Januvia's IRA MFP Termination
Policy· June 14, 2026 · 13 min read