FDA Foreign Drug Establishment Registration Guide
FDA foreign drug establishment registration: timing, site DUNS, U.S. agent and importers, annual renewal, SPL filing and approval boundaries.
FDA Labeler Code Checklist for Foreign Companies
FDA labeler code checklist covering DUNS, SPL submission routes, the 30-day update scope, and conditional two-year deactivation.
FXR0906 Clinical Trial China: Fosun Evidence Check
FXR0906 clinical trial China: what Fosun reported about NMPA clinical-trial approval, what remains unknown about Phase 1, and evidence boundaries.
FDA Global Generic Drug Affairs: Overseas Team Guide
What FDA Global Generic Drug Affairs does and does not do: Generic Drug Cluster, PSA pilot, and ANDA submission boundaries for overseas teams.
FDA Drug Registration and Listing: A Pre-Workshop Compliance Map for Manufacturers
FDA drug registration and listing compliance map: current SPL, EDRLS, and 510(j)(3) duties, plus the future 12-digit NDC timeline.
GDUFA III Controlled Correspondence: Scope, Submission Rules, and Eligibility Map for Generic Drug Developers
GDUFA III decision map for generic drug developers: controlled vs general correspondence, pre-ANDA meetings, post-CRL, PSG, and CPA boundaries.
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.
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.