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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-2009" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-0007 FDA None FDA-2022-E-2009 Letter to U.S. Patent and Trademark Office Other Letter(s) 2025-01-27T05:00:00Z 2025 1 2025-01-27T05:00:00Z   2025-01-27T16:57:37Z   0 0 09000064868ffc56
FDA-2022-E-2009-0006 FDA None FDA-2022-E-2009 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   2024-02-27T15:44:06Z   0 0 09000064863e550b
FDA-2022-E-2009-0005 FDA None FDA-2022-E-2009 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   2023-12-29T14:11:49Z   0 0 0900006486365c63
FDA-2022-E-2009-0004 FDA None FDA-2022-E-2009 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 2023-12-21T15:26:24Z 2023-28094 0 0 090000648634e3d3
FDA-2022-E-2009-0003 FDA None FDA-2022-E-2009 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   2022-09-28T20:26:17Z   0 0 090000648537b1d2
FDA-2022-E-2009-0001 FDA None FDA-2022-E-2009 Letter from U S Patent and Trademark Office Other Letter(s) 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:32:19Z   0 0 0900006485273371
FDA-2022-E-2009-0002 FDA None FDA-2022-E-2009 Patent Term Extension Application for LYBALVI® Patent No 7,262,298 Other Application 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T13:34:02Z   0 0 090000648527348d

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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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