RLB-US-2026-00001 — RegLegBrief Citation

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RLB-US-2026-00001

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 Schedule

Issuing body Food and Drug Administration Jurisdiction US Signal date 06 April 2026 Status Cited — Original document preserved by RLB Regulatory reference 91 FR 17284 Document type Notice

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RegLegBrief (reglegbrief.com) — 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 Schedule Regulatory reference: 91 FR 17284 US — 06 April 2026 Issuing body: Food and Drug Administration Status: Cited — Original document preserved by RLB Available at: https://reglegbrief.com/cite/RLB-US-2026-00001 Citation ID: RLB-US-2026-00001

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