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
Regulatory
Regulatory strategy, FDA and EMA submissions, postmarketing requirements, accelerated approval obligations, and lifecycle compliance.
Manufacturing· August 25, 2026 · 15 min read
FDA's 2026 CCS Draft Replaces 1999 Packaging Guidance, Not Biosimilar Devices
By Ran Chen#CMC#Manufacturing#Combination Product
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
Policy· August 24, 2026 · 20 min read
HHS Vaccine-Category RFI: What SCDM Means for ACA and VFC Coverage Clocks
By Ran Chen#Policy#Coverage Access#Payer Policy
Generics· August 23, 2026 · 17 min read
FDA's August 2026 TE Final: 505(b)(2) Requests and Orange Book Blanks
By Ran Chen#Orange Book#505(b)(2)#FDA Approval
Policy· August 21, 2026 · 19 min read
Reject China Trial Data Without Audits: What the Moolenaar Letter Would Do
By Ran Chen#Clinical Trials#Regulatory#China
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 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
Pipeline· July 30, 2026 · 19 min read
Companion Diagnostics (2026): FDA PMA Supplement Expansion & Device Landscape
By Ran Chen#Companion Diagnostic#FDA Approval#Oncology