Articles
Practical guides on FDA adverse-event reporting, E2B(R3) XML, FAERS/AEMS data analysis, and per-drug safety profiles. Written by the team behind AdverseEvent.ai.
How to Submit Your E2B(R3) ICSR File to the FDA: A Step-by-Step Guide
You have already generated the E2B(R3) XML file. Now let's submit it to the FDA's FAERS database. If you've never sent a safety report to the FDA electronically before, this can feel intimidating — there are gateways, acknowledgments, certificates, and a lot of acronyms. The good news: for most small and mid-size companies, the simplest path is a web portal where you log in and upload your file, much like attaching a document to an email. This guide walks you through that path, called the Unified Submission Portal (USP), from start to finish.
How to Report a Cosmetic Serious Adverse Event Under MoCRA: A 2026 Responsible Person's Guide
What cosmetics brands must do under MoCRA: who counts as the Responsible Person, what makes an adverse event “serious,” the 15-business-day reporting clock, and the three FDA submission paths — ESG XML, the Safety Reporting Portal, and paper Form 3500A.
Semaglutide vs Tirzepatide vs Liraglutide: A FAERS/AEMS Adverse Event Comparison (2026)
Side-by-side comparison of semaglutide, tirzepatide, and liraglutide adverse event reports in FAERS/AEMS. Where the GLP-1 drugs differ, where their data has quality issues, and what you can and can't conclude.
How to Generate E2B(R3) XML for FAERS/AEMS Submission: A Complete 2026 Guide
How to generate valid E2B(R3) XML for FAERS/AEMS submission before the October 1, 2026 deadline. Covers the validation pipeline, nullFlavors, the LSMV validator, and migration from E2B(R2).
Ozempic (Semaglutide) Adverse Events in FAERS/AEMS: A 2026 Analysis
Real FAERS/AEMS data on Ozempic (semaglutide) adverse events: disproportionality signals, emerging trends, gastroparesis, NAION, and what the numbers actually say about safety.
How to Fill Out FDA Form 3500A: A Complete 2026 Guide
A practical 2026 guide to FDA Form 3500A: section-by-section field guidance, common rejection reasons, OCR and AI shortcuts, and what changed with the AEMS transition.