Policy· August 25, 2026 · 15 min read
Wound PFDD Does Not Reset Skin-Substitute Pay; 351 BLAs Would Face Rebates
By Ran Chen#Medicare Part B#CMS#Drug Pricing
Topic
FDA
FDA approvals, guidance, safety updates, labeling, advisory committees, and US regulatory operations.
Manufacturing· August 24, 2026 · 17 min read
FDA's ACTIMP Potency Guidance: Personalized Peptide and Neoantigen Lot Release
By Ran Chen#CMC#Manufacturing Capacity#Pipeline
Generics· August 22, 2026 · 17 min read
FDA's August 2026 PSG Batch: Development Clock vs Orange Book Exclusivity
By Ran Chen#Generics#Orange Book#FDA
Biosimilars· August 17, 2026 · 18 min read
FDA Biosimilar Device Guidance: Presentations That Are Not Interchangeable
By Ran Chen#Biosimilars#Interchangeability#Purple Book
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
Manufacturing· August 5, 2026 · 21 min read
2026 oncology injectable shortage: ifosfamide, carboplatin & buy-and-bill
By Ran Chen#Supply Chain#Oncology#Manufacturing
Policy· August 3, 2026 · 13 min read
FDA Guidance Documents by the Numbers (2026): Fewer Issued, More Drafts
By Ran Chen#FDA#Regulatory#Policy
Manufacturing· July 26, 2026 · 17 min read
FDA Drug Shortages by the Numbers: 2026 National Registry Analysis
Manufacturing· July 23, 2026 · 20 min read
Diabetes Device UDI Landscape by Manufacturer (2026)
Approvals· July 16, 2026 · 22 min read