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withdrawn,object_id
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,,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,,2024-07-31T20:10:49Z,,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,,2024-07-31T20:10:40Z,,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,,2024-07-31T20:10:54Z,,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,,2024-07-31T20:10:30Z,,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,,2024-07-31T20:10:35Z,,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,,2024-07-31T20:10:45Z,,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,,2023-12-20T15:44:09Z,,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,,2023-11-13T19:25:02Z,,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,,2023-11-03T18:01:50Z,,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,,2023-10-24T21:11:43Z,,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,,2023-10-23T19:12:01Z,,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,,2023-10-23T19:20:10Z,,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,,2023-06-05T14:13:04Z,,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,,,2023-05-30T12:43:39Z,,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,,2023-04-28T12:29:34Z,,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,,2024-11-07T00:49:31Z,,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,,2023-04-14T16:17:20Z,,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,,,2023-04-14T13:49:43Z,,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,,2023-04-14T13:42:16Z,,0,0,090000648594930c
FDA-2021-N-0874-0073,FDA,FDA-2021-N-0874,"Comment on Citizen Petition: Intarcia Therapeutics, Inc.’s 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,,2023-04-14T13:42:42Z,,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,,2023-04-14T16:17:25Z,,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,,2023-03-27T12:57:18Z,,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,,2023-03-22T18:35:04Z,,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,,2023-02-27T19:14:12Z,,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,,2023-02-15T21:13:51Z,,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,,2023-02-07T20:26:45Z,,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,,2022-10-13T18:09:33Z,,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,,2022-10-11T16:50:14Z,,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,,2022-09-13T18:40:16Z,,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,,2022-09-09T16:08:46Z,,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,,2022-08-26T18:32:47Z,,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,,2022-07-27T20:34:09Z,,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,,2022-04-29T18:01:52Z,,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,,2022-04-18T18:45:57Z,,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,,2022-03-25T15:46:13Z,,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,,2022-03-24T14:27:29Z,,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,,2022-03-01T19:22:01Z,,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,,2022-02-19T02:00:27Z,,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,,2021-12-29T13:57:57Z,,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,,2021-09-13T20:06:58Z,,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