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withdrawn,object_id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-0874-0085,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