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42 rows where docket_id = "FDA-2021-N-0874" sorted by posted_date descending
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document_type 3
agency_id 1
- FDA 42
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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