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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-0501" 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 4
  • 2026 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0501-0006 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT Notice Determinations 2026-04-16T04:00:00Z 2026 4 2026-04-16T04:00:00Z 2026-06-16T03:59:59Z 2026-04-16T17:49:56Z 2026-07422 1 0 09000064b928671f
FDA-2025-E-0501-0005 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 Letter to U.S. Patent and Trademark Office Other Letter(s) 2026-03-18T04:00:00Z 2026 3 2026-03-18T04:00:00Z   2026-03-19T00:18:04Z   0 0 09000064b9222e52
FDA-2025-E-0501-0004 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2025-12-18T05:00:00Z 2025 12 2025-12-18T05:00:00Z   2025-12-19T02:30:58Z   0 0 09000064b90f02b1
FDA-2025-E-0501-0003 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 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   2025-12-18T21:55:14Z   0 0 09000064b900681d
FDA-2025-E-0501-0001 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 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   2025-02-28T18:40:49Z   0 0 09000064869951bf
FDA-2025-E-0501-0002 FDA Patent Term Extension Application for UNLOXCYT® (cosibelimab-ipdl), Patent No. 10,590,199 FDA-2025-E-0501 Patent Extension Application from Foley & Lardner LLP (on behalf of Checkpoint Therapeutics, Inc.) Other Application 2025-02-28T05:00:00Z 2025 2 2025-02-28T05:00:00Z   2025-02-28T18:43:43Z   0 0 09000064869951c0

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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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