Manufacturing· September 8, 2026 · 23 min read
Topic
Policy
Federal healthcare legislation, executive orders, agency regulations, and trade policy affecting pharmaceutical markets.
Policy· September 7, 2026 · 34 min read
EClinCloud AI-Assisted Study Build: What Sponsors Must Accept Before EDC Go-Live
By Ran Chen#FDA#Regulatory#Clinical Trials
Policy· August 30, 2026 · 17 min read
FDA Licensed XFG COVID Vaccines: Part B Differs from ACIP and ACA 2713
Generics· August 27, 2026 · 17 min read
FDA's Cabazitaxel 314.161 Notice: ANDAs to Dead 10 mg/mL NDA, Not Jevtana Kit
By Ran Chen#Generics#Orange Book#505(b)(2)
Policy· August 24, 2026 · 18 min read
FDA's Expedited IND Pilot: 30-Day Safe-to-Proceed Clock and QRI Review
By Ran Chen#FDA Approval#Clinical Evidence#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
Policy· August 23, 2026 · 16 min read
CMS-10110 Turns Quarterly ASP Into a Part B MFP Compliance Feed: Comments Oct 20
By Ran Chen#CMS#ASP#Medicare Part B
Pricing & Access· August 22, 2026 · 17 min read
CMS's 340B OPPS Cut: ASP Minus 33.4%, the 2026 Survey, and August 31 Clock
By Ran Chen#340B#CMS#Medicare Part B
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
Policy· August 20, 2026 · 19 min read
CMS-4215-P Comment Docket: Manufacturers and Hospitals Clash on IRA Rules
By Ran Chen#IRA Negotiation#Policy#Payer Policy