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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

13 rows where docket_id = "FDA-2019-E-1960" 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

  • 2024 7
  • 2019 2
  • 2022 2
  • 2023 2

document_type 2

  • Other 12
  • Notice 1

agency_id 1

  • FDA 13
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1960-0013 FDA None FDA-2019-E-1960 Response to Notice of Final Determination and Requirement for Election of Patent Term Extension Application Other Letter(s) 2024-08-09T04:00:00Z 2024 8 2024-08-09T04:00:00Z   2024-08-09T20:42:52Z   0 0 0900006486612edd
FDA-2019-E-1960-0012 FDA None FDA-2019-E-1960 Certificate Extending Patent Term Other Certificate Extending Patent Term 2024-07-31T04:00:00Z 2024 7 2024-07-31T04:00:00Z   2024-07-31T12:12:14Z   0 0 0900006486605ee2
FDA-2019-E-1960-0011 FDA None FDA-2019-E-1960 Notice of Final Determination and Requirement for Election Other Letter(s) 2024-03-18T04:00:00Z 2024 3 2024-03-18T04:00:00Z   2024-03-18T19:20:06Z   0 0 090000648647b459
FDA-2019-E-1960-0009 FDA None FDA-2019-E-1960 Requirement for Information Pursuant to 37 CFR 1.750 Other Letter(s) 2024-03-18T04:00:00Z 2024 3 2024-03-18T04:00:00Z   2024-03-18T19:19:41Z   0 0 090000648647b9c1
FDA-2019-E-1960-0010 FDA None FDA-2019-E-1960 Response to Requirement for Information Pursuant to 37 CFR 1.750 Other Response(s) 2024-03-18T04:00:00Z 2024 3 2024-03-18T04:00:00Z   2024-03-18T19:19:54Z   0 0 090000648647b9d6
FDA-2019-E-1960-0008 FDA None FDA-2019-E-1960 Letter from FDA CDER to U S Patent and Trademark Office Other Letter(s) 2024-02-05T05:00:00Z 2024 2 2024-02-05T05:00:00Z   2024-02-05T15:16:14Z   0 0 09000064863da07b
FDA-2019-E-1960-0007 FDA None FDA-2019-E-1960 Letter from U. S. Patent and Trademark Office to FDA CDER Other Letter(s) 2024-01-17T05:00:00Z 2024 1 2024-01-17T05:00:00Z   2024-01-17T19:19:27Z   0 0 0900006486390176
FDA-2019-E-1960-0006 FDA None FDA-2019-E-1960 Determination of Regulatory Review Period for Purposes of Patent Extension; LOKELMA Notice Determinations 2023-02-08T05:00:00Z 2023 2 2023-02-08T05:00:00Z 2023-04-11T03:59:59Z 2024-02-05T15:16:40Z 2023-02667 0 0 090000648563f05a
FDA-2019-E-1960-0005 FDA None FDA-2019-E-1960 Letter from FDA CDER TO U.S. Patent and Trademark Office Other Letter(s) 2023-02-02T05:00:00Z 2023 2 2023-02-02T05:00:00Z   2023-02-02T17:34:16Z   0 0 0900006485627359
FDA-2019-E-1960-0004 FDA None FDA-2019-E-1960 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   2022-12-29T21:21:35Z   0 0 090000648555f86c
FDA-2019-E-1960-0003 FDA None FDA-2019-E-1960 Letter from FDA to U.S. Patent and Trademark Office Other Letter(s) 2022-05-31T04:00:00Z 2022 5 2022-05-31T04:00:00Z   2022-05-31T14:57:07Z   0 0 0900006483d30dc9
FDA-2019-E-1960-0002 FDA None FDA-2019-E-1960 Patent Extension Application from Arent Fox LLP (on behalf of ZS Pharma, Inc.) Other Application 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-04-24T12:29:16Z   0 0 0900006483be9e77
FDA-2019-E-1960-0001 FDA None FDA-2019-E-1960 Letter from U.S. Patent and Trademark Office Other Letter(s) 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-04-24T12:25:43Z   0 0 0900006483be9e46

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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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