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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-2019-E-2271" 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

  • 2019 3
  • 2022 3
  • 2023 1
  • 2024 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-E-2271-0008 FDA None FDA-2019-E-2271 Notice of Final Determination and Requirement for Election Letter Other Letter(s) 2024-03-06T05:00:00Z 2024 3 2024-03-06T05:00:00Z   2024-03-06T18:46:57Z   0 0 09000064863f4859
FDA-2019-E-2271-0007 FDA None FDA-2019-E-2271 Letter to U. S. Patent and Trademark Office Other Letter(s) 2023-07-13T04:00:00Z 2023 7 2023-07-13T04:00:00Z   2023-07-13T17:57:33Z   0 0 0900006485c9f74a
FDA-2019-E-2271-0006 FDA None FDA-2019-E-2271 Determination of Regulatory Review Period for Purposes of Patent Extension; PREVYMIS IV Solution, New Drug Application 209940 Notice Determinations 2022-11-14T05:00:00Z 2022 11 2022-11-14T05:00:00Z 2023-01-14T04:59:59Z 2022-11-14T16:28:59Z 2022-24719 0 0 09000064854aac1b
FDA-2019-E-2271-0005 FDA None FDA-2019-E-2271 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2022-09-08T04:00:00Z 2022 9 2022-09-08T04:00:00Z   2022-09-08T16:20:47Z   0 0 09000064852ce342
FDA-2019-E-2271-0004 FDA None FDA-2019-E-2271 Letter from Office of Patent Legal Administration/ Office of the Deputy Commissioner for Patents to FDA CDER Other Letter(s) 2022-05-27T04:00:00Z 2022 5 2022-05-27T04:00:00Z   2022-05-27T18:09:00Z   0 0 0900006485100826
FDA-2019-E-2271-0003 FDA None FDA-2019-E-2271 Letter from FDA to U.S. Patent and Trademark Office Other Letter(s) 2019-06-21T04:00:00Z 2019 6 2022-05-27T04:00:00Z   2022-05-27T17:36:10Z   0 0 0900006483d31a50
FDA-2019-E-2271-0002 FDA None FDA-2019-E-2271 Patent Extension Application from Millen White Zelano & Branigan PC (on behalf of AiCuris Anti-infective Cures GmbH) Other Application 2019-05-09T04:00:00Z 2019 5 2019-05-09T04:00:00Z   2019-05-09T16:03:22Z   0 0 0900006483c4df14
FDA-2019-E-2271-0001 FDA None FDA-2019-E-2271 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2019-05-09T04:00:00Z 2019 5 2019-05-09T04:00:00Z   2019-05-09T15:58:13Z   0 0 0900006483c4de33

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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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