Cell and Gene Therapy BLA Readiness: What FDA’s OTP Town Hall Transcript Clarifies
FDA transcript-backed guide to CGT BLA filing readiness: pre-BLA meetings, CBER checklists, eCTD validation, and refuse-to-file prevention.
FYZSXNB Blog
Casgevy for Children Aged 2 and Older: Direct Pediatric Evidence, FDA Extrapolation, and Long-Term Unknowns
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: A Product-by-Product Pre-Workshop Checklist
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.
Model-Integrated Evidence for Generic Drugs: What an FDA Meeting Request Must Explain
Before requesting an FDA MIE meeting, generic-drug developers must explain their model, evidence integration, and ICH M15 alignment. See the full checklist.
Bambu Lab из Китая для России: что проверить по модели, LAN-режиму и поддержке до покупки
Гид до покупки Bambu Lab из Китая для России: как проверить модель, регион прошивки, LAN-Only режим и поддержку. Что подтверждено, а что — «Не подтверждено».
Digitally Derived Endpoints: A Sponsor Readiness Checklist Before FDA’s August 2026 Workshop
Sponsor readiness checklist for FDA’s August 2026 digitally derived endpoints workshop. Covers estimands, validation, data standards, and sensitivity analysis.
FDA 2026 CGT CMC Guidance: What Is Flexible and Required
A practical guide to FDA’s May 2026 CGT CMC flexibilities, PPQ, specifications, stability, platform knowledge and what BLAs still must show.
Как проверить регистрацию китайской IVD в России
Пошаговая проверка китайской IVD-системы в реестре Росздравнадзора: статус, модель, REF, производитель, назначение, документы и отзывы.
2026—2028年俄罗斯与EAEU医疗器械注册过渡期：中国IVD厂家路线图
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。
TB Test LoD: What 10 vs 100 CFU/mL Really Means
Learn why analytical LoD is not clinical sensitivity and how to evaluate 10 versus 100 CFU/mL claims in molecular tuberculosis tests.