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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

12 rows where docket_id = "FDA-2021-N-0874" and posted_year = 2022 sorted by posted_date descending

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posted_year 1

  • 2022 · 12 ✖

document_type 1

  • Other 12

agency_id 1

  • FDA 12
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0874-0065 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

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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;
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