{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2021-N-0874\" sorted by posted_date descending", "rows": [["FDA-2021-N-0874-0092", "FDA", "FDA-2021-N-0874", "Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650", "Notice", "General Notice", "2024-08-23T04:00:00Z", 2024, 8, "2024-08-23T04:00:00Z", null, "2024-08-23T18:25:03Z", "2024-18898", 0, 0, "090000648666c365"], ["FDA-2021-N-0874-0090", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee Meeting Transcript", "Other", "Transcript(s)", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:49Z", null, 0, 0, "090000648661047d"], ["FDA-2021-N-0874-0088", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee Intarcia Briefing Document", "Other", "Brief", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:40Z", null, 0, 0, "0900006486610463"], ["FDA-2021-N-0874-0091", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee Meeting Questions", "Other", "Request", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:54Z", null, 0, 0, "0900006486610480"], ["FDA-2021-N-0874-0086", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee CDER PowerPoint Presentation", "Other", "Presentation", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:30Z", null, 0, 0, "090000648661045d"], ["FDA-2021-N-0874-0087", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee FDA Briefing Document", "Other", "Brief", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:35Z", null, 0, 0, "090000648661045f"], ["FDA-2021-N-0874-0089", "FDA", "FDA-2021-N-0874", "September 21, 2023 Endocrinologic and Metabolic Drugs Advisory Committee Intarcia PowerPoint Presentation", "Other", "Presentation", "2024-07-31T04:00:00Z", 2024, 7, "2024-07-31T04:00:00Z", null, "2024-07-31T20:10:45Z", null, 0, 0, "090000648661047a"], ["FDA-2021-N-0874-0085", "FDA", "FDA-2021-N-0874", "Letter from FDA CDER to OCS", "Other", "Letter(s)", "2023-12-20T05:00:00Z", 2023, 12, "2023-12-20T05:00:00Z", null, "2023-12-20T15:44:09Z", null, 0, 0, "090000648634b732"], ["FDA-2021-N-0874-0084", "FDA", "FDA-2021-N-0874", "Intarcia Appeal Exceptions Re ITCA 650 EMDAC Hearing - Material Issues Of Fact On Record Vs DDLO Assertions - Sub To Dr. Bumpus 10-10-23 FF_", "Other", "Presentation", "2023-11-13T05:00:00Z", 2023, 11, "2023-11-13T05:00:00Z", null, "2023-11-13T19:25:02Z", null, 0, 0, "09000064861e3c29"], ["FDA-2021-N-0874-0083", "FDA", "FDA-2021-N-0874", "Intarcia's Appeal of EMDAC Hearing Initial Decision - Exceptions Filed Material Issues of Fact For Dr. Bumpus @ FDA 10-10-23", "Other", "Decision", "2023-11-03T04:00:00Z", 2023, 11, "2023-11-03T04:00:00Z", null, "2023-11-03T18:01:50Z", null, 0, 0, "09000064861e2089"], ["FDA-2021-N-0874-0082", "FDA", "FDA-2021-N-0874", "ITCA 650, clarifying facts about CDERs erroneous statements about device performance", "Other", "Correspondence", "2023-10-24T04:00:00Z", 2023, 10, "2023-10-24T04:00:00Z", null, "2023-10-24T21:11:43Z", null, 0, 0, "09000064861294a1"], ["FDA-2021-N-0874-0080", "FDA", "FDA-2021-N-0874", "A Brief Summary of the Medici Technology & ITCA 650", "Other", "Summary (SUM)", "2023-10-23T04:00:00Z", 2023, 10, "2023-10-23T04:00:00Z", null, "2023-10-23T19:12:01Z", null, 0, 0, "0900006486124e1b"], ["FDA-2021-N-0874-0081", "FDA", "FDA-2021-N-0874", "Letter from Technical Operations, Intarcia to FDA OC", "Other", "Letter(s)", "2023-10-23T04:00:00Z", 2023, 10, "2023-10-23T04:00:00Z", null, "2023-10-23T19:20:10Z", null, 0, 0, "0900006486124e1d"], ["FDA-2021-N-0874-0079", "FDA", "FDA-2021-N-0874", "Letter from FDA OC to Hogan Lovells LLP RE Intarcia Therapeutics, Inc. Hearing Request for NDA 209053", "Other", "Letter(s)", "2023-06-05T04:00:00Z", 2023, 6, "2023-06-05T04:00:00Z", null, "2023-06-05T14:13:04Z", null, 0, 0, "0900006485ab986e"], ["FDA-2021-N-0874-0078", "FDA", "FDA-2021-N-0874", "Comment from Hogan Lovells US LLP", "Supporting & Related Material", "Background Material", "2023-05-30T04:00:00Z", 2023, 5, null, null, "2023-05-30T12:43:39Z", null, 0, 0, "0900006485a4835c"], ["FDA-2021-N-0874-0077", "FDA", "FDA-2021-N-0874", "Letter from FDA OC Re Intarcia Therapeutics, Inc. Hearing Request for NDA 209053 ITCA 650 (exenatide in DUROS device)", "Other", "Letter(s)", "2023-04-28T04:00:00Z", 2023, 4, "2023-04-28T04:00:00Z", null, "2023-04-28T12:29:34Z", null, 0, 0, "090000648599a397"], ["FDA-2021-N-0874-0071", "FDA", "FDA-2021-N-0874", "Citizen Petition from Hogan Lovells US LLP on behalf of Intarcia Therapeutics Inc", "Other", "Citizen Petition", "2023-04-14T04:00:00Z", 2023, 4, "2023-04-14T04:00:00Z", null, "2024-11-07T00:49:31Z", null, 1, 0, "0900006485942f3f"], ["FDA-2021-N-0874-0075", "FDA", "FDA-2021-N-0874", "April 3 2023 Meeting Minutes re ITCA 650", "Other", "Minutes", "2023-04-14T04:00:00Z", 2023, 4, "2023-04-14T04:00:00Z", null, "2023-04-14T16:17:20Z", null, 0, 0, "090000648594a13c"], ["FDA-2021-N-0874-0074", "FDA", "FDA-2021-N-0874", "Attachment 1 RE: Citizen Petition from Hogan Lovells US LLP on behalf of Intarcia Therapeutics Inc", "Supporting & Related Material", "Background Material", "2023-04-14T04:00:00Z", 2023, 4, null, null, "2023-04-14T13:49:43Z", null, 0, 0, "0900006485949310"], ["FDA-2021-N-0874-0072", "FDA", "FDA-2021-N-0874", "Acknowledgment Letter from FDA DMS to Hogan Lovells US LLP on behalf of Intarcia", "Other", "Acknowledgement Letter/Receipt", "2023-04-14T04:00:00Z", 2023, 4, "2023-04-14T04:00:00Z", null, "2023-04-14T13:42:16Z", null, 0, 0, "090000648594930c"], ["FDA-2021-N-0874-0073", "FDA", "FDA-2021-N-0874", "Comment on Citizen Petition: Intarcia Therapeutics, Inc.\u2019s Request for a Part 14 Hearing on ITCA 650 RE Citizen Petition from Hogan Lovells US LLP on behalf of Intarcia Therapeutics Inc", "Other", "Response(s)", "2023-04-14T04:00:00Z", 2023, 4, "2023-04-14T04:00:00Z", null, "2023-04-14T13:42:42Z", null, 0, 0, "090000648594930e"], ["FDA-2021-N-0874-0076", "FDA", "FDA-2021-N-0874", "Letter to Intarcia and CDER re ITCA 650 April 14 2023 final", "Other", "Letter(s)", "2023-04-14T04:00:00Z", 2023, 4, "2023-04-14T04:00:00Z", null, "2023-04-14T16:17:25Z", null, 0, 0, "090000648594a13e"], ["FDA-2021-N-0874-0070", "FDA", "FDA-2021-N-0874", "Letter from FDA CDER to Hogan Lovells LLP and FDA OC", "Other", "Letter(s)", "2023-03-27T04:00:00Z", 2023, 3, "2023-03-27T04:00:00Z", null, "2023-03-27T12:57:18Z", null, 0, 0, "09000064858473d9"], ["FDA-2021-N-0874-0069", "FDA", "FDA-2021-N-0874", "Memorandum - Separation of Functions; Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing", "Other", "Memorandum", "2023-03-22T04:00:00Z", 2023, 3, "2023-03-22T04:00:00Z", null, "2023-03-22T18:35:04Z", null, 0, 0, "0900006485824496"], ["FDA-2021-N-0874-0068", "FDA", "FDA-2021-N-0874", "Letter from Hogan Lovells US LLP", "Other", "Letter(s)", "2023-02-27T05:00:00Z", 2023, 2, "2023-02-27T05:00:00Z", null, "2023-02-27T19:14:12Z", null, 0, 0, "09000064856d5437"], ["FDA-2021-N-0874-0067", "FDA", "FDA-2021-N-0874", "CDER Memo Re Intarcia Part 14 FINAL", "Other", "Memorandum", "2023-02-15T05:00:00Z", 2023, 2, "2023-02-15T05:00:00Z", null, "2023-02-15T21:13:51Z", null, 0, 0, "09000064856a3c6c"], ["FDA-2021-N-0874-0066", "FDA", "FDA-2021-N-0874", "Letter from FDA OC to Hogan Lovells LLP and FDA CDER", "Other", "Letter(s)", "2023-02-07T05:00:00Z", 2023, 2, "2023-02-07T05:00:00Z", null, "2023-02-07T20:26:45Z", null, 0, 0, "090000648563c2dc"], ["FDA-2021-N-0874-0065", "FDA", "FDA-2021-N-0874", "REDACTED CDER_Proposed Order FDA-2021-N-0874", "Other", "Memo", "2022-10-13T04:00:00Z", 2022, 10, "2022-10-13T04:00:00Z", null, "2022-10-13T18:09:33Z", null, 0, 0, "0900006485401637"], ["FDA-2021-N-0874-0064", "FDA", "FDA-2021-N-0874", "Letter from Hogan Lovells US LLP (Intarcia Therapeutics, Inc.)", "Other", "Letter(s)", "2022-10-11T04:00:00Z", 2022, 10, "2022-10-11T04:00:00Z", null, "2022-10-11T16:50:14Z", null, 0, 0, "09000064853e869c"], ["FDA-2021-N-0874-0063", "FDA", "FDA-2021-N-0874", "Letter from Hogan Lovells LLP (Intarcia)", "Other", "Letter(s)", "2022-09-13T04:00:00Z", 2022, 9, "2022-09-13T04:00:00Z", null, "2022-09-13T18:40:16Z", null, 0, 0, "09000064852d546c"], ["FDA-2021-N-0874-0062", "FDA", "FDA-2021-N-0874", "Letter from Lunenfeld-Tanenbaum Research Institute to FDA CDER", "Other", "Letter(s)", "2022-09-09T04:00:00Z", 2022, 9, "2022-09-09T04:00:00Z", null, "2022-09-09T16:08:46Z", null, 0, 0, "09000064852dabc1"], ["FDA-2021-N-0874-0061", "FDA", "FDA-2021-N-0874", "Response to Intarcia Counsel 8 26 22", "Other", "Agency Response", "2022-08-26T04:00:00Z", 2022, 8, "2022-08-26T04:00:00Z", null, "2022-08-26T18:32:47Z", null, 0, 0, "090000648527b72a"], ["FDA-2021-N-0874-0059", "FDA", "FDA-2021-N-0874", "Letter to Matthew Warren from FDA CDER", "Other", "Letter(s)", "2022-07-27T04:00:00Z", 2022, 7, "2022-07-27T04:00:00Z", null, "2022-07-27T20:34:09Z", null, 0, 0, "09000064851ee675"], ["FDA-2021-N-0874-0058", "FDA", "FDA-2021-N-0874", "OCC Separation of Functions Memo Intarcia", "Other", "Letter(s)", "2022-04-29T04:00:00Z", 2022, 4, "2022-04-29T04:00:00Z", null, "2022-04-29T18:01:52Z", null, 0, 0, "090000648504421f"], ["FDA-2021-N-0874-0057", "FDA", "FDA-2021-N-0874", "Intarcia Letter April 15 22", "Other", "Letter(s)", "2022-04-18T04:00:00Z", 2022, 4, "2022-04-18T04:00:00Z", null, "2022-04-18T18:45:57Z", null, 0, 0, "0900006485020cf6"], ["FDA-2021-N-0874-0056", "FDA", "FDA-2021-N-0874", "Letter from Hogan Lovells US LLP to Office of the Commissioner", "Other", "Letter(s)", "2022-03-25T04:00:00Z", 2022, 3, "2022-03-25T04:00:00Z", null, "2022-03-25T15:46:13Z", null, 0, 0, "0900006484fd6e37"], ["FDA-2021-N-0874-0055", "FDA", "FDA-2021-N-0874", "Intarcia Therapeutics, Inc. Hearing Request for NDA 209053 ITCA 650 (exenatide in DUROS device)", "Other", "Letter(s)", "2022-03-24T04:00:00Z", 2022, 3, "2022-03-24T04:00:00Z", null, "2022-03-24T14:27:29Z", null, 0, 0, "0900006484fde8d1"], ["FDA-2021-N-0874-0054", "FDA", "FDA-2021-N-0874", "Intarcia Therapeutics, Inc. Hearing Request for NDA 209053 ITCA 650 (exenatide) implant", "Other", "Letter(s)", "2022-03-01T05:00:00Z", 2022, 3, "2022-03-01T05:00:00Z", null, "2022-03-01T19:22:01Z", null, 0, 0, "0900006484fb4468"], ["FDA-2021-N-0874-0053", "FDA", "FDA-2021-N-0874", "Supplement from Hogan Lovells US LLP", "Other", "Supplement (SUP)", "2022-02-17T05:00:00Z", 2022, 2, "2022-02-17T05:00:00Z", null, "2022-02-19T02:00:27Z", null, 0, 0, "0900006484f7e6ae"], ["FDA-2021-N-0874-0052", "FDA", "FDA-2021-N-0874", "Intarcia Letter to Office of the Commissioner", "Other", "Letter(s)", "2021-12-29T05:00:00Z", 2021, 12, "2021-12-29T05:00:00Z", null, "2021-12-29T13:57:57Z", null, 0, 0, "0900006484f0006f"], ["FDA-2021-N-0874-0002", "FDA", "FDA-2021-N-0874", "Request for Hearing from Hogan Lovells US LLP (Intarcia Therapeutics Inc.)", "Other", "Request for Hearing", "2021-09-13T04:00:00Z", 2021, 9, "2021-09-13T04:00:00Z", null, "2021-09-13T20:06:58Z", null, 0, 0, "0900006484d795f2"], ["FDA-2021-N-0874-0001", "FDA", "FDA-2021-N-0874", "Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing", "Notice", "General Notice", "2021-09-02T04:00:00Z", 2021, 9, "2021-09-02T04:00:00Z", "2021-11-02T03:59:59Z", "2024-11-12T23:33:26Z", "2021-18928", 1, 0, "0900006484d4387c"]], "truncated": false, "filtered_table_rows_count": 42, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["id", "agency_id", "docket_id", "title", "document_type", "subtype", "posted_date", "posted_year", "posted_month", "comment_start_date", "comment_end_date", "last_modified", "fr_doc_num", "open_for_comment", "withdrawn", "object_id"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select id, agency_id, docket_id, title, document_type, subtype, posted_date, posted_year, posted_month, comment_start_date, comment_end_date, last_modified, fr_doc_num, open_for_comment, withdrawn, object_id from documents where \"agency_id\" = :p0 and \"docket_id\" = :p1 order by posted_date desc limit 101", "params": {"p0": "FDA", "p1": "FDA-2021-N-0874"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874", "results": [{"value": "FDA", "label": "FDA", "count": 42, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2021-N-0874", "selected": true}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874", "results": [{"value": "Other", "label": "Other", "count": 38, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&document_type=Other", "selected": false}, {"value": "Notice", "label": "Notice", "count": 2, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&document_type=Notice", "selected": false}, {"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 2, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&document_type=Supporting+%26+Related+Material", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874", "results": [{"value": 2023, "label": 2023, "count": 20, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&posted_year=2023", "selected": false}, {"value": 2022, "label": 2022, "count": 12, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&posted_year=2022", "selected": false}, {"value": 2024, "label": 2024, "count": 7, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&posted_year=2024", "selected": false}, {"value": 2021, "label": 2021, "count": 3, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&posted_year=2021", "selected": false}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet=subtype"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet=posted_month"}, {"name": "comment_start_date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet=comment_start_date"}, {"name": "open_for_comment", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet=open_for_comment"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet_date=comment_start_date"}, {"name": "comment_end_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet_date=comment_end_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2021-N-0874&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 2041.226102039218, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}