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
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2
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Open
Last activity
Jun 1, 2026
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Rules, notices, and supporting material — the primary rule pinned first.
- Notice· Apr 6, 2026Open · 58 days left💬 2
