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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-2019-E-1076" 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 2

  • 2019 5
  • 2020 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-E-1076-0007 FDA None FDA-2019-E-1076 Patent Term Extension letter from FDA CDER to U S Patent and Trademark Office Other Letter(s) 2020-07-27T04:00:00Z 2020 7 2020-07-28T04:00:00Z   2020-07-28T16:20:49Z   0 0 09000064847aca7f
FDA-2019-E-1076-0006 FDA None FDA-2019-E-1076 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2020-06-22T04:00:00Z 2020 6 2020-06-22T04:00:00Z   2020-06-22T17:37:15Z   0 0 09000064846feccc
FDA-2019-E-1076-0005 FDA None FDA-2019-E-1076 Determination of Regulatory Review Period for Purposes of Patent Extension: PALYNZIQ Notice Determinations 2019-12-06T05:00:00Z 2019 12 2019-12-06T05:00:00Z 2020-06-04T03:59:59Z 2019-12-06T14:19:08Z 2019-26327 0 0 09000064841ed563
FDA-2019-E-1076-0004 FDA None FDA-2019-E-1076 Letter from FDA CDER to U S Patent and Trademark Office Other Letter(s) 2019-11-01T04:00:00Z 2019 11 2019-11-01T04:00:00Z   2019-11-01T19:25:57Z   0 0 0900006484116418
FDA-2019-E-1076-0003 FDA None FDA-2019-E-1076 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2019-05-13T04:00:00Z 2019 5 2019-05-13T04:00:00Z   2019-05-13T19:05:21Z   0 0 0900006483c73e5f
FDA-2019-E-1076-0002 FDA None FDA-2019-E-1076 Patent Extension Application for PALYNZIQ Patent No. 7,534,595 Other Application 2019-03-06T05:00:00Z 2019 3 2019-03-06T05:00:00Z   2019-03-06T17:48:51Z   0 0 0900006483ac4c70
FDA-2019-E-1076-0001 FDA None FDA-2019-E-1076 Letter from U S Patent and Trademark Office Other Letter(s) 2019-03-06T05:00:00Z 2019 3 2019-03-06T05:00:00Z   2019-03-06T17:47:35Z   0 0 0900006483ac4f4e

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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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