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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

10 rows where docket_id = "FDA-2019-E-3294" 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

  • 2019 3
  • 2023 3
  • 2024 3
  • 2022 1

document_type 2

  • Other 9
  • Notice 1

agency_id 1

  • FDA 10
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-3294-0010 FDA None FDA-2019-E-3294 Withdrawal of Application for Patent Term Extension Other Letter(s) 2024-07-31T04:00:00Z 2024 7 2024-07-31T04:00:00Z   2024-07-31T12:12:42Z   0 0 0900006486605ee4
FDA-2019-E-3294-0009 FDA None FDA-2019-E-3294 Notice of Final Determination and Requirement for Election Letter from U.S. Patent and Trademark Office to Kilpatrick Townsend & Stockton LLP – West Coast Other Letter(s) 2024-02-28T05:00:00Z 2024 2 2024-02-28T05:00:00Z   2024-02-28T20:48:52Z   0 0 090000648641d71f
FDA-2019-E-3294-0008 FDA None FDA-2019-E-3294 Requirement for Information from U. S. Patent and Trademark Office to Wenderoth, Lind & Ponack, L.L.P. Other Letter(s) 2024-02-21T05:00:00Z 2024 2 2024-02-21T05:00:00Z   2024-02-21T19:34:16Z   0 0 09000064863e8595
FDA-2019-E-3294-0007 FDA None FDA-2019-E-3294 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2023-11-15T05:00:00Z 2023 11 2023-11-15T05:00:00Z   2023-11-15T18:54:52Z   0 0 090000648627d167
FDA-2019-E-3294-0006 FDA None FDA-2019-E-3294 Determination of Regulatory Review Period for Purposes of Patent Extension; MULPLETA Notice Determinations 2023-03-22T04:00:00Z 2023 3 2023-03-22T04:00:00Z 2023-05-23T03:59:59Z 2023-03-22T15:02:53Z 2023-05799 0 0 0900006485812259
FDA-2019-E-3294-0005 FDA None FDA-2019-E-3294 Letter to U.S. Patent and Trademark Office from FDA CDER Other Letter(s) 2023-03-09T05:00:00Z 2023 3 2023-03-09T05:00:00Z   2023-03-09T18:16:09Z   0 0 0900006485779284
FDA-2019-E-3294-0004 FDA None FDA-2019-E-3294 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2022-12-29T05:00:00Z 2022 12 2022-12-29T05:00:00Z   2022-12-29T21:23:36Z   0 0 090000648555fa82
FDA-2019-E-3294-0003 FDA None FDA-2019-E-3294 Letter to U.S. Patent and Trademark Office from FDA CDER Other Letter(s) 2019-10-29T04:00:00Z 2019 10 2019-10-29T04:00:00Z   2019-10-29T20:26:47Z   0 0 0900006484106cee
FDA-2019-E-3294-0001 FDA None FDA-2019-E-3294 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2019-07-09T04:00:00Z 2019 7 2019-07-09T04:00:00Z   2019-07-09T14:07:55Z   0 0 0900006483d6e110
FDA-2019-E-3294-0002 FDA None FDA-2019-E-3294 Patent Extension Application from Wenderoth Lind & Ponack LLP (on behalf of Shionogi & Co., Ltd.) Other Application 2019-07-09T04:00:00Z 2019 7 2019-07-09T04:00:00Z   2019-07-09T14:13:47Z   0 0 0900006483d6e111

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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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