Research archive
Source-backed biomed industry news, regulation, clinical development, medtech, import/export platforms, and market signals. Not medical advice.
GDUFA III decision map for generic drug developers: controlled vs general correspondence, pre-ANDA meetings, post-CRL, PSG, and CPA boundaries.
FDA transcript-backed guide to CGT BLA filing readiness: pre-BLA meetings, CBER checklists, eCTD validation, and refuse-to-file prevention.
Casgevy’s July 1, 2026 FDA approval covers ages 2+, but direct pediatric data spans ages 5 to under 12. See what FDA extrapolated and what remains unknown.
GLP-1 generic development is not one pathway. This pre-FDA/CRCG checklist covers reference products, Orange Book vs Purple Book, peptide routes, and devices.
Before requesting an FDA MIE meeting, generic-drug developers must explain their model, evidence integration, and ICH M15 alignment. See the full checklist.
Sponsor readiness checklist for FDA’s August 2026 digitally derived endpoints workshop. Covers estimands, validation, data standards, and sensitivity analysis.
A practical guide to FDA’s May 2026 CGT CMC flexibilities, PPQ, specifications, stability, platform knowledge and what BLAs still must show.
2026年1月起俄罗斯临时适用EAEU IVD注册过渡议定书。本指南详解2027/2028关键日期、俄罗斯国家注册与EAEU注册路线对比、决策树、证据清单及常见误读，助中国IVD厂商制定合规策略。
Learn why analytical LoD is not clinical sensitivity and how to evaluate 10 versus 100 CFU/mL claims in molecular tuberculosis tests.
Evidence-based procurement guide for the iFIND IFQ INH/FQ fluoroquinolone resistance cartridge: brochure claims, evidence gaps, and a 12-point checklist.