dockets: FDA-2016-D-1280

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2016-D-1280 FDA 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) Nonrulemaking 2026-06-11T16:00:41Z 0b00006481fd2f23         ["2015-286", "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", "(FAERS)"] CDER International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA     {"displayProperties": [{"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["2015-286", "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", "(FAERS)"], "modifyDate": "2026-06-11T16:00:41Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA", "subType2": null, "title": "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)", "generic": "D", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "Open", "effectiveDate": null, "objectId": "0b00006481fd2f23"} single_get

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