dockets: FDA-2019-D-4751

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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-2019-D-4751 FDA FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry; Availability Nonrulemaking 2021-05-25T08:48:34Z 0b0000648407b7e6         ["FDARA Implementation Guidance for Pediatric", "FDARA Implementation Guidance for Pediatric", "Studies of Molecularly Targeted Oncology Drugs:", "Studies of Molecularly Targeted Oncology Drugs:", "to Sec. 505B of the FD&C Act", "to Sec. 505B of the FD&C Act", "Draft Guidance", "Draft Guidance", "OPEN", "OPEN", "FRDTS 2019-14", "Oncology Center of Excellence", "OPEN", "FRDTS 2019-14", "Oncology Center of Excellence", "OPEN"] CDER FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry; Availability     {"displayProperties": [{"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the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": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["FDARA Implementation Guidance for Pediatric", "FDARA Implementation Guidance for Pediatric", "Studies of Molecularly Targeted Oncology Drugs:", "Studies of Molecularly Targeted Oncology Drugs:", "to Sec. 505B of the FD&C Act", "to Sec. 505B of the FD&C Act", "Draft Guidance", "Draft Guidance", "OPEN", "OPEN", "FRDTS 2019-14", "Oncology Center of Excellence", "OPEN", "FRDTS 2019-14", "Oncology Center of Excellence", "OPEN"], "modifyDate": "2021-05-25T08:48:34Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry; Availability", "subType2": null, "title": "FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act; Draft Guidance for Industry; Availability", "generic": "D", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": null, "effectiveDate": null, "objectId": "0b0000648407b7e6"} single_get

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