
Section
Policy
CMS, FDA, HHS, Federal Register, and payer-policy moves that change the rules under commercial teams.
44 articles · Last updated

Policy· August 16, 2026 · 15 min read
By Ran Chen#PBM#Payer Policy#Formulary Strategy

Policy· August 14, 2026 · 18 min read
FDA AEMS Explained: FAERS Replacement, Dashboard, & Safety Pipelines
By Ran Chen#Policy#FDA Approval#Clinical Evidence
Policy· August 12, 2026 · 38 min read
IARC Group 1 Call on HCTZ, Voriconazole, Tacrolimus: Pharma & P&T Actions
By Ran Chen#FDA#Label Warnings#Formulary Strategy

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
EU Joint Clinical Assessments under the HTA Regulation: 2026 market access guide

Policy· August 7, 2026 · 14 min read
EUDAMED mandatory 2026: EU device database scale, actors, and MDR deadlines
By Ran Chen#Policy#Regulatory#Supply Chain

Policy· August 3, 2026 · 13 min read
FDA Guidance Documents by the Numbers (2026): Fewer Issued, More Drafts
By Ran Chen#FDA#Regulatory#Policy

Policy· August 2, 2026 · 29 min read
EU Clinical Trials by the Numbers 2026: 12,123 CTIS Records Analyzed
By Ran Chen#Clinical Trials#EMA#Clinical Evidence

Policy· July 29, 2026 · 25 min read
FDA 503A Wellness-Peptide Vote (July 2026): Six Peptides and the Bulk-List Process

Policy· July 28, 2026 · 22 min read
Trump's Generic Drug Tariff: The 2028–2029 Onshoring Timeline and US Import Exposure
By Ran Chen#Generic Drugs#Tariffs#Manufacturing