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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-2021-E-1091" 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

  • 2021 3
  • 2024 2
  • 2022 1
  • 2023 1
  • 2025 1

document_type 3

  • Other 6
  • Notice 1
  • Supporting & Related Material 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-E-1091-0008 FDA None FDA-2021-E-1091 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2025-01-13T05:00:00Z 2025 1 2025-01-13T05:00:00Z   2025-01-13T20:15:50Z   0 0 09000064868b81fb
FDA-2021-E-1091-0007 FDA None FDA-2021-E-1091 Letter from U. S. Patent and Trademark Office Other Letter(s) 2024-03-06T05:00:00Z 2024 3 2024-03-06T05:00:00Z   2024-03-06T18:42:43Z   0 0 09000064863ef547
FDA-2021-E-1091-0006 FDA None FDA-2021-E-1091 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2024-01-18T05:00:00Z 2024 1 2024-01-18T05:00:00Z   2024-01-18T21:29:54Z   0 0 09000064863a94ba
FDA-2021-E-1091-0005 FDA None FDA-2021-E-1091 Determination of Regulatory Review Period for Purposes of Patent Extension; Pemazyre Notice Determinations 2023-12-08T05:00:00Z 2023 12 2023-12-08T05:00:00Z 2024-02-07T04:59:59Z 2023-12-08T14:47:16Z 2023-26996 0 0 0900006486316628
FDA-2021-E-1091-0004 FDA None FDA-2021-E-1091 Letter to U S Patent and Trademark Office Other Letter(s) 2022-09-08T04:00:00Z 2022 9 2022-09-08T04:00:00Z   2022-09-08T16:38:08Z   0 0 09000064852ce9e0
FDA-2021-E-1091-0002 FDA None FDA-2021-E-1091 Patent Extension Application from Fish & Richardson P.C. (on behalf of Incyte Corporation) Other Application 2021-10-12T04:00:00Z 2021 10 2021-10-12T04:00:00Z   2021-10-12T14:56:45Z   0 0 0900006484dc20b5
FDA-2021-E-1091-0001 FDA None FDA-2021-E-1091 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2021-10-12T04:00:00Z 2021 10 2021-10-12T04:00:00Z   2021-10-12T14:56:37Z   0 0 0900006484dc24f8
FDA-2021-E-1091-0003 FDA None FDA-2021-E-1091 Appendix A re Patent Extension Application from Fish & Richardson P.C. (on behalf of Incyte Corporation) Supporting & Related Material Background Material 2021-10-12T04:00:00Z 2021 10     2021-10-12T14:56:53Z   0 0 0900006484dc20b7

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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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