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
FDA-2016-D-1280-0005Notice
Comments
2
Last activity Jun 1, 2026
Deadline
64 days
Closes Oct 2, 2026
Net supportiSupport minus oppose · campaigns included
0%
0% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- 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
- Posted
- Apr 6, 2026
- Comment period
- Apr 6, 2026 – Oct 2, 2026
- FR Doc
- 2026-06660
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
0%
Net support
Other2
Aggregates include form-letter campaigns. Excluding them, net support is 0% across organic comments.
Who commented
Breakdown by commenter type.
Individual
2
Comments over time
Weekly arrivals, stacked by stance.
Posted Apr 6, 2026Deadline Oct 2, 2026
Apr 6Jun 1
Support0Oppose0Other2
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
0%
0%
100%
Issues raised
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Comments
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- Jun 1, 2026Comment from Biljana KorkisOtherIndividualRead comment →
- Apr 6, 2026Comment from Sofia Dana SantelicesOtherIndividual📎 Attachment
The commenter is a private individual who expresses personal grievances regarding alleged harassment, data privacy violations, and human rights abuses. The comment does not address the specific proposed action regarding E2B(R3) data standards for safety reports.
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