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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

7 rows where docket_id = "FDA-2022-E-2010" sorted by posted_date descending

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Suggested facets: 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 1
  • 2025 1

document_type 2

  • Other 6
  • Notice 1

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-0007 FDA None FDA-2022-E-2010 Letter to U.S. Patent and Trademark Office Other Letter(s) 2025-01-27T05:00:00Z 2025 1 2025-01-27T05:00:00Z   2025-01-27T16:58:37Z   0 0 09000064868ffc58
FDA-2022-E-2010-0006 FDA None FDA-2022-E-2010 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   2024-02-27T15:44:24Z   0 0 09000064863e5521
FDA-2022-E-2010-0005 FDA None FDA-2022-E-2010 Letter to U. S. Patent and Trademark Office from FDA CDER Other Letter(s) 2023-12-29T05:00:00Z 2023 12 2023-12-29T05:00:00Z   2023-12-29T14:12:02Z   0 0 0900006486365697
FDA-2022-E-2010-0004 FDA None FDA-2022-E-2010 Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALV Notice Determinations 2023-12-21T05:00:00Z 2023 12 2023-12-21T05:00:00Z 2024-02-21T04:59:59Z 2023-12-21T15:29:45Z 2023-28094 0 0 090000648634e3d4
FDA-2022-E-2010-0003 FDA None FDA-2022-E-2010 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2022-09-28T04:00:00Z 2022 9 2022-09-28T04:00:00Z   2022-09-28T20:28:25Z   0 0 090000648537ac31
FDA-2022-E-2010-0001 FDA None FDA-2022-E-2010 Letter from U S Patent and Trademark Office Other Letter(s) 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:43:26Z   0 0 0900006485273492
FDA-2022-E-2010-0002 FDA None FDA-2022-E-2010 Patent Term Extension Application for LYBALVI® Patent No 9,119,848 Other Application 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:45:09Z   0 0 09000064852734fa

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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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