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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

6 rows where docket_id = "FDA-2025-E-0491" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 2

  • 2025 5
  • 2026 1

document_type 2

  • Other 5
  • Notice 1

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-E-0491-0006 FDA None FDA-2025-E-0491 Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY Notice Determinations 2026-02-13T05:00:00Z 2026 2 2026-02-13T05:00:00Z 2026-04-15T03:59:59Z 2026-02-13T19:34:31Z 2026-02973 1 0 09000064b91aa8fb
FDA-2025-E-0491-0005 FDA None FDA-2025-E-0491 Letter to U. S. Patent and Trademark Office Other Letter(s) 2025-12-03T05:00:00Z 2025 12 2025-12-03T05:00:00Z   2025-12-03T20:20:00Z   0 0 09000064b90aa0d8
FDA-2025-E-0491-0004 FDA None FDA-2025-E-0491 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2025-11-05T05:00:00Z 2025 11 2025-11-05T05:00:00Z   2025-11-05T22:15:24Z   0 0 09000064b9069bb4
FDA-2025-E-0491-0003 FDA None FDA-2025-E-0491 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2025-10-10T04:00:00Z 2025 10 2025-10-10T04:00:00Z   2025-10-10T22:31:37Z   0 0 09000064b900703d
FDA-2025-E-0491-0002 FDA None FDA-2025-E-0491 Patent Extension Application from Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. (on behalf of Neurocrine Biosciences, Inc.) Other Application 2025-02-28T05:00:00Z 2025 2 2025-02-28T05:00:00Z   2025-02-28T18:31:31Z   0 0 090000648699142f
FDA-2025-E-0491-0001 FDA None FDA-2025-E-0491 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2025-02-28T05:00:00Z 2025 2 2025-02-28T05:00:00Z   2025-02-28T18:25:26Z   0 0 090000648699142e

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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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