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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-2018-N-1262" and posted_year = 2024 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), last_modified (date)

posted_year 1

  • 2024 · 8 ✖

document_type 1

  • Notice 8

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-1262-0025 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib) Notice Notice of Approval 2024-10-15T04:00:00Z 2024 10     2024-10-15T14:35:39Z 2024-23651 0 0 09000064867ce6bb
FDA-2018-N-1262-0024 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab) Notice Announcement 2024-10-11T04:00:00Z 2024 10 2024-10-11T04:00:00Z   2024-10-11T14:35:40Z 2024-23629 0 0 09000064867c9627
FDA-2018-N-1262-0023 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib) Notice General Notice 2024-09-11T04:00:00Z 2024 9     2024-09-11T13:16:31Z 2024-20556 0 0 09000064866ea193
FDA-2018-N-1262-0022 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) Notice Announcement 2024-07-17T04:00:00Z 2024 7 2024-07-17T04:00:00Z   2024-07-17T13:00:19Z 2024-15695 0 0 09000064865f4739
FDA-2018-N-1262-0018 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2024-01-23T05:00:00Z 2024 1 2024-01-23T05:00:00Z   2024-01-23T15:06:50Z 2024-01156 0 0 09000064863b8649
FDA-2018-N-1262-0019 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2024-01-23T05:00:00Z 2024 1 2024-01-23T05:00:00Z   2024-01-23T15:31:45Z 2024-01164 0 0 09000064863b88d4
FDA-2018-N-1262-0021 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2024-01-23T05:00:00Z 2024 1 2024-01-23T05:00:00Z   2024-01-23T15:57:05Z 2024-01160 0 0 09000064863b9236
FDA-2018-N-1262-0020 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2024-01-23T05:00:00Z 2024 1 2024-01-23T05:00:00Z   2024-01-23T15:55:32Z 2024-01163 0 0 09000064863b9166

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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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