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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

8 rows where docket_id = "FDA-2022-E-2016" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2022 3
  • 2023 2
  • 2024 2
  • 2025 1

document_type 2

  • Other 7
  • Notice 1

agency_id 1

  • FDA 8
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-E-2016-0008 FDA None FDA-2022-E-2016 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2025-01-13T05:00:00Z 2025 1 2025-01-13T05:00:00Z   2025-01-13T20:52:07Z   0 0 09000064868b7c09
FDA-2022-E-2016-0007 FDA None FDA-2022-E-2016 Letter from U.S. Patent and Trademark Office to DECHERT LLP Other Letter(s) 2024-02-27T05:00:00Z 2024 2 2024-02-27T05:00:00Z   2024-02-27T15:37:43Z   0 0 09000064863e5621
FDA-2022-E-2016-0006 FDA None FDA-2022-E-2016 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2024-02-27T05:00:00Z 2024 2 2024-02-27T05:00:00Z   2024-02-27T15:37:37Z   0 0 09000064863e561c
FDA-2022-E-2016-0005 FDA None FDA-2022-E-2016 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2023-12-29T05:00:00Z 2023 12 2023-12-29T05:00:00Z   2023-12-29T14:10:40Z   0 0 0900006486365692
FDA-2022-E-2016-0004 FDA None FDA-2022-E-2016 Determination of Regulatory Review Period for Purposes of Patent Extension; Fotivda Notice Determinations 2023-12-08T05:00:00Z 2023 12 2023-12-08T05:00:00Z 2024-02-07T04:59:59Z 2023-12-08T14:30:04Z 2023-26997 0 0 0900006486316031
FDA-2022-E-2016-0003 FDA None FDA-2022-E-2016 Letter to U S Patent and Trademark Office Other Letter(s) 2022-09-13T04:00:00Z 2022 9 2022-09-13T04:00:00Z   2022-09-13T17:18:02Z   0 0 09000064852f93d6
FDA-2022-E-2016-0002 FDA None FDA-2022-E-2016 Cover Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T15:56:42Z   0 0 0900006485274af3
FDA-2022-E-2016-0001 FDA None FDA-2022-E-2016 Patent Extension Application from Goodwin Procter LLP on behalf of Kyowa Kirin Co., Ltd. Other Application 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T15:56:22Z   0 0 09000064852744a6

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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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