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dockets: FDA-2022-D-2997

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

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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-2022-D-2997 FDA Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations; Draft Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Availability Nonrulemaking 2024-05-06T17:29:58Z 0b000064854ff493   OPEN     ["Key Information and Facilitating Understanding", "in Informed Consent for FDA-Regulated Clinical", "Investigations;", "FRDTS 2016-1049", "OPEN", "CDER"] CDER Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations; Draft Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Avai     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"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": ["Key Information and Facilitating Understanding", "in Informed Consent for FDA-Regulated Clinical", "Investigations;", "FRDTS 2016-1049", "OPEN", "CDER"], "modifyDate": "2024-05-06T17:29:58Z", "dkAbstract": "OPEN", "agencyId": "FDA", "program": "CDER", "shortTitle": "Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations; Draft Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Avai", "subType2": null, "title": "Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations; Draft Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Availability", "generic": "D", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064854ff493"} single_get

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