documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
20 rows where docket_id = "FDA-2021-N-0874" and posted_year = 2023 sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | 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 |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;