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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

29 rows where docket_id = "FDA-2018-N-1262" 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 6

  • 2022 8
  • 2024 8
  • 2019 5
  • 2025 4
  • 2018 3
  • 2020 1

document_type 1

  • Notice 29

agency_id 1

  • FDA 29
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1262-0029 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept) Notice Notice of Approval 2025-04-23T04:00:00Z 2025 4     2025-04-23T13:35:52Z 2025-06969 0 0 0900006486aa96be
FDA-2018-N-1262-0028 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AMVUTTRA (vutrisiran) Notice Notice of Approval 2025-04-21T04:00:00Z 2025 4     2025-04-21T13:40:16Z 2025-06785 0 0 0900006486aa4378
FDA-2018-N-1262-0027 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab) Notice Notice of Approval 2025-04-21T04:00:00Z 2025 4     2025-04-21T13:37:12Z 2025-06784 0 0 0900006486aa43b7
FDA-2018-N-1262-0026 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) Notice Announcement 2025-01-10T05:00:00Z 2025 1 2025-01-10T05:00:00Z   2025-01-10T13:56:06Z 2025-00341 0 0 09000064868addd8
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
FDA-2018-N-1262-0017 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-12-14T05:00:00Z 2022 12 2022-12-14T05:00:00Z   2022-12-14T14:00:50Z 2022-27138 0 0 0900006485535ce4
FDA-2018-N-1262-0016 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-12-07T05:00:00Z 2022 12 2022-12-07T05:00:00Z   2022-12-07T16:17:58Z 2022-26565 0 0 09000064855212b5
FDA-2018-N-1262-0015 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-11-25T05:00:00Z 2022 11 2022-11-25T05:00:00Z   2022-11-25T14:45:36Z 2022-25644 0 0 0900006485500679
FDA-2018-N-1262-0014 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-09-08T04:00:00Z 2022 9 2022-09-08T04:00:00Z   2022-09-08T14:34:06Z 2022-19384 0 0 09000064852c9f6b
FDA-2018-N-1262-0013 FDA None FDA-2018-N-1262 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2022-09-07T04:00:00Z 2022 9 2022-09-07T04:00:00Z   2022-09-07T12:52:36Z 2022-19276 0 0 09000064852bf70e
FDA-2018-N-1262-0012 FDA None FDA-2018-N-1262 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2022-09-06T04:00:00Z 2022 9 2022-09-06T04:00:00Z   2022-09-06T13:34:10Z 2022-19155 0 0 09000064852b409b
FDA-2018-N-1262-0011 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-06-27T04:00:00Z 2022 6 2022-06-27T04:00:00Z   2022-06-27T13:14:32Z 2022-13628 0 0 090000648519efa6
FDA-2018-N-1262-0010 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2022-06-24T04:00:00Z 2022 6 2022-06-24T04:00:00Z   2022-06-24T12:52:29Z 2022-13607 0 0 090000648518bcf9
FDA-2018-N-1262-0009 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2020-06-01T04:00:00Z 2020 6 2020-06-01T04:00:00Z   2020-06-01T14:19:14Z 2020-11681 0 0 09000064846bf562
FDA-2018-N-1262-0008 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2019-12-16T05:00:00Z 2019 12 2019-12-16T05:00:00Z   2019-12-16T15:12:52Z 2019-27054 0 0 0900006484212720
FDA-2018-N-1262-0007 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Notice of Approval 2019-10-25T04:00:00Z 2019 10 2019-10-25T04:00:00Z   2019-10-25T12:49:49Z 2019-23252 0 0 09000064840f8b96
FDA-2018-N-1262-0006 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Announcement 2019-09-06T04:00:00Z 2019 9 2019-09-06T04:00:00Z   2019-09-06T13:45:31Z 2019-19298 0 0 0900006483f0482d
FDA-2018-N-1262-0005 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Announcement 2019-06-04T04:00:00Z 2019 6 2019-06-04T04:00:00Z   2019-06-04T13:21:02Z 2019-11522 0 0 0900006483ce690b
FDA-2018-N-1262-0004 FDA None FDA-2018-N-1262 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Announcement 2019-05-03T04:00:00Z 2019 5 2019-05-03T04:00:00Z   2019-05-06T14:59:30Z 2019-09005 0 0 0900006483c2de53
FDA-2018-N-1262-0003 FDA None FDA-2018-N-1262 Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice Announcement 2018-11-23T05:00:00Z 2018 11 2018-11-23T05:00:00Z   2018-11-23T20:50:10Z 2018-25480 0 0 09000064838f5b5b
FDA-2018-N-1262-0002 FDA None FDA-2018-N-1262 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2018-10-25T04:00:00Z 2018 10 2018-10-25T04:00:00Z   2018-10-25T13:55:20Z 2018-23308 0 0 09000064838490b7
FDA-2018-N-1262-0001 FDA None FDA-2018-N-1262 Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers Notice Notice of Approval 2018-04-10T04:00:00Z 2018 4 2018-04-10T04:00:00Z   2018-04-10T14:31:13Z 2018-07256 0 0 09000064830f4b4a

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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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