International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)
🏛 Food and Drug Administration (FDA)FDA-2016-D-1280
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1
Total comments
2
all analyzed
Comment status
Open
Last activity
Jun 1, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
NoticeApr 6, 2026
Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International
Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation ScheduleOpen · 58 days left💬 2 comments