documents

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-2020-E-2363" 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 5

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2020-E-2363-0010 FDA None FDA-2020-E-2363 Notice of Final Determination and Requirement for Election Other Letter(s) 2024-07-31T04:00:00Z 2024 7 2024-07-31T04:00:00Z   2024-07-31T12:06:12Z   0 0 0900006486605ecb
FDA-2020-E-2363-0009 FDA None FDA-2020-E-2363 Letter from FDA CDER to U S Patent and Trademark Office Other Letter(s) 2023-07-13T04:00:00Z 2023 7 2023-07-13T04:00:00Z   2023-07-13T16:49:42Z   0 0 0900006485ca2173
FDA-2020-E-2363-0008 FDA None FDA-2020-E-2363 Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction Notice Correction 2023-05-24T04:00:00Z 2023 5 2023-05-24T04:00:00Z   2023-05-24T13:12:34Z 2023-10979 0 0 0900006485a47735
FDA-2020-E-2363-0007 FDA None FDA-2020-E-2363 Response Letter from FDA CDER to Fish & Richardson, P.C. Other Letter(s) 2023-05-16T04:00:00Z 2023 5 2023-05-16T04:00:00Z   2023-05-16T14:27:04Z   0 0 0900006485a0db46
FDA-2020-E-2363-0006 FDA None FDA-2020-E-2363 Request for Revision of Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG Other Petition(s) 2022-09-09T04:00:00Z 2022 9 2022-09-09T04:00:00Z   2022-09-09T13:49:26Z   0 0 09000064852cdc6d
FDA-2020-E-2363-0005 FDA None FDA-2020-E-2363 Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG Notice Determinations 2022-07-13T04:00:00Z 2022 7 2022-07-13T04:00:00Z 2022-09-13T03:59:59Z 2023-05-24T13:12:10Z 2022-14930 0 0 09000064851c6d74
FDA-2020-E-2363-0004 FDA None FDA-2020-E-2363 Letter from FDA CDER to U S Patent and Trademark Office Other Letter(s) 2022-06-14T04:00:00Z 2022 6 2022-06-14T04:00:00Z   2022-06-14T17:43:26Z   0 0 0900006485162ed1
FDA-2020-E-2363-0003 FDA None FDA-2020-E-2363 Patent Term Extension Letter from FDA CDER to Honorable Drew Hirshfeld Other Extension of Time 2021-03-01T05:00:00Z 2021 3 2021-03-01T05:00:00Z   2021-03-01T18:59:14Z   0 0 0900006484a585bd
FDA-2020-E-2363-0001 FDA None FDA-2020-E-2363 Letter from U S Patent and Trademark Office Other Letter(s) 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2020-12-31T14:46:23Z   0 0 09000064849d6369
FDA-2020-E-2363-0002 FDA None FDA-2020-E-2363 Patent Term Extension Application for ENSPRYNG® Patent No 10,662,245 Other Application 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2020-12-31T14:47:19Z   0 0 09000064849d636a

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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;