dockets: FDA-2024-P-1871

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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-2024-P-1871 FDA Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent, bioequivalent, and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labeling Nonrulemaking 2026-05-21T16:11:13Z 0b000064864db12e   Open     ["CDER", "Citizen Petition", "Advanced Accelerator Applications USA, Inc.", "A Novartis Company", "Requests the Commissioner to ensure that", "applications submitted under 505(j) and", "505(b)(2) that rely on Lutathera include data", "necessary to show that a proposed product is", "pharmaceutically equivalent, bioequivalent, and", "can be expected to have the same clinical effect", "and safety profile as Lutathera when", "administered to patients under the conditions", "specified in the labeling, including Total", "Activity at time of injection, Specific Activity", "at time of calibration, and individual patient", "doses filled in the range 20.5-25.0 mL to", "ensure Total Activity of 7.4 GBq at time of", "injection", "Open"] CDER Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent,     {"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": ["CDER", "Citizen Petition", "Advanced Accelerator Applications USA, Inc.", "A Novartis Company", "Requests the Commissioner to ensure that", "applications submitted under 505(j) and", "505(b)(2) that rely on Lutathera include data", "necessary to show that a proposed product is", "pharmaceutically equivalent, bioequivalent, and", "can be expected to have the same clinical effect", "and safety profile as Lutathera when", "administered to patients under the conditions", "specified in the labeling, including Total", "Activity at time of injection, Specific Activity", "at time of calibration, and individual patient", "doses filled in the range 20.5-25.0 mL to", "ensure Total Activity of 7.4 GBq at time of", "injection", "Open"], "modifyDate": "2026-05-21T16:11:13Z", "dkAbstract": "Open", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent,", "subType2": null, "title": "Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent, bioequivalent, and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labeling", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064864db12e"} single_get

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