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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

36 rows where docket_id = "FDA-2020-N-0026" sorted by posted_date descending

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posted_year 6

  • 2024 9
  • 2020 8
  • 2021 7
  • 2023 6
  • 2022 3
  • 2025 3

document_type 1

  • Notice 36

agency_id 1

  • FDA 36
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2020-N-0026-0036 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib) Notice Announcement 2025-03-13T04:00:00Z 2025 3 2025-03-13T04:00:00Z   2025-03-13T12:56:52Z 2025-04021 0 0 09000064869e6ed4
FDA-2020-N-0026-0035 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci) Notice General Notice 2025-01-15T05:00:00Z 2025 1     2025-01-15T14:35:52Z 2025-00750 0 0 09000064868c0464
FDA-2020-N-0026-0034 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont) Notice Announcement 2025-01-10T05:00:00Z 2025 1 2025-01-10T05:00:00Z   2025-01-10T13:53:44Z 2025-00340 0 0 09000064868ade79
FDA-2020-N-0026-0033 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AQNEURSA (Levacetylleucine) Notice Announcement 2024-10-15T04:00:00Z 2024 10     2024-10-15T18:42:22Z 2024-23712 0 0 09000064867ce892
FDA-2020-N-0026-0032 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MIPLYFFA (Arimoclomol) Notice Announcement 2024-10-15T04:00:00Z 2024 10     2024-10-15T18:42:10Z 2024-23646 0 0 09000064867ce712
FDA-2020-N-0026-0031 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat) Notice Announcement 2024-08-28T04:00:00Z 2024 8 2024-08-28T04:00:00Z   2024-08-28T13:55:40Z 2024-19334 0 0 09000064866b0229
FDA-2020-N-0026-0030 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; XOLREMDI (mavorixafor) Notice Announcement 2024-05-16T04:00:00Z 2024 5     2024-05-16T12:55:40Z 2024-10715 0 0 0900006486568fbb
FDA-2020-N-0026-0029 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OJEMDA (tovorafenib) Notice Announcement 2024-05-15T04:00:00Z 2024 5 2024-05-15T04:00:00Z   2024-05-15T13:21:52Z 2024-10583 0 0 0900006486566994
FDA-2020-N-0026-0028 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat) Notice Announcement 2024-04-11T04:00:00Z 2024 4 2024-04-11T04:00:00Z   2024-04-11T14:00:15Z 2024-07657 0 0 09000064864cd930
FDA-2020-N-0026-0026 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2024-01-11T05:00:00Z 2024 1 2024-01-11T05:00:00Z   2024-01-11T14:57:56Z 2024-00400 0 0 09000064863921da
FDA-2020-N-0026-0027 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2024-01-11T05:00:00Z 2024 1 2024-01-11T05:00:00Z   2024-01-11T17:10:21Z 2024-00401 0 0 090000648639237b
FDA-2020-N-0026-0025 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2024-01-09T05:00:00Z 2024 1 2024-01-09T05:00:00Z   2024-01-09T14:08:36Z 2024-00263 0 0 09000064863887b3
FDA-2020-N-0026-0024 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2023-12-05T05:00:00Z 2023 12 2023-12-05T05:00:00Z   2023-12-05T17:53:57Z 2023-26652 0 0 09000064862f4366
FDA-2020-N-0026-0023 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2023-06-06T04:00:00Z 2023 6 2023-06-06T04:00:00Z   2023-06-06T13:56:37Z 2023-11907 0 0 0900006485ac482e
FDA-2020-N-0026-0022 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2023-04-24T04:00:00Z 2023 4 2023-04-24T04:00:00Z   2023-04-24T13:13:08Z 2023-08518 0 0 090000648597a166
FDA-2020-N-0026-0021 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2023-03-30T04:00:00Z 2023 3 2023-03-30T04:00:00Z   2023-03-30T17:50:15Z 2023-06593 0 0 090000648588ded3
FDA-2020-N-0026-0020 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2023-03-16T04:00:00Z 2023 3 2023-03-16T04:00:00Z   2023-03-16T14:40:38Z 2023-05364 0 0 09000064857b8ed4
FDA-2020-N-0026-0019 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2023-03-16T04:00:00Z 2023 3 2023-03-16T04:00:00Z   2023-03-16T14:29:35Z 2023-05355 0 0 09000064857b8f16
FDA-2020-N-0026-0018 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2022-10-07T04:00:00Z 2022 10 2022-10-07T04:00:00Z   2022-10-07T15:04:36Z 2022-21865 0 0 09000064853d3898
FDA-2020-N-0026-0017 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2022-10-07T04:00:00Z 2022 10 2022-10-07T04:00:00Z   2022-10-07T14:34:49Z 2022-21851 0 0 09000064853d3853
FDA-2020-N-0026-0016 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2022-08-29T04:00:00Z 2022 8 2022-08-29T04:00:00Z   2022-08-29T19:19:19Z 2022-18519 0 0 0900006485285365
FDA-2020-N-0026-0015 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2021-10-27T04:00:00Z 2021 10 2021-10-27T04:00:00Z   2022-08-29T19:17:39Z 2021-23336 0 0 0900006484dfa50e
FDA-2020-N-0026-0014 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal Notice Withdrawal 2021-10-06T04:00:00Z 2021 10 2021-10-06T04:00:00Z   2022-08-29T19:17:24Z 2021-21823 0 0 0900006484dbc501
FDA-2020-N-0026-0013 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2021-09-30T04:00:00Z 2021 9 2021-09-30T04:00:00Z   2022-08-29T19:17:13Z 2021-21311 0 0 0900006484db3d0f
FDA-2020-N-0026-0012 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2021-07-02T04:00:00Z 2021 7 2021-07-02T04:00:00Z   2022-08-29T19:16:59Z 2021-14191 0 0 0900006484bcc3e6
FDA-2020-N-0026-0010 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2021-03-12T05:00:00Z 2021 3 2021-03-12T05:00:00Z   2022-08-29T19:16:27Z 2021-05208 0 0 0900006484a68d9d
FDA-2020-N-0026-0011 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2021-03-12T05:00:00Z 2021 3 2021-03-12T05:00:00Z   2022-08-29T19:16:45Z 2021-05207 0 0 0900006484a68e24
FDA-2020-N-0026-0009 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2021-02-16T05:00:00Z 2021 2 2021-02-16T05:00:00Z   2022-08-29T19:16:13Z 2021-03012 0 0 0900006484a38031
FDA-2020-N-0026-0008 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher: Rare Pediatric Disease Product Notice General Notice 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T18:16:44Z 2020-27760 0 0 09000064849a4513
FDA-2020-N-0026-0007 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice General Notice 2020-12-17T05:00:00Z 2020 12 2020-12-17T05:00:00Z   2020-12-17T16:38:06Z 2020-27778 0 0 09000064849a448f
FDA-2020-N-0026-0006 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-12-07T05:00:00Z 2020 12 2020-12-07T05:00:00Z   2020-12-07T16:10:20Z 2020-26801 0 0 0900006484989f80
FDA-2020-N-0026-0005 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-09-16T04:00:00Z 2020 9 2020-09-16T04:00:00Z   2020-09-16T13:13:28Z 2020-20387 0 0 090000648485c8f0
FDA-2020-N-0026-0004 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-09-15T04:00:00Z 2020 9 2020-09-15T04:00:00Z   2020-09-15T13:29:33Z 2020-20320 0 0 09000064848591c8
FDA-2020-N-0026-0003 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-09-04T04:00:00Z 2020 9 2020-09-04T04:00:00Z   2020-09-04T12:54:43Z 2020-19604 0 0 09000064848446df
FDA-2020-N-0026-0002 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-08-25T04:00:00Z 2020 8 2020-08-25T04:00:00Z   2020-08-25T12:58:38Z 2020-18648 0 0 090000648481d0d5
FDA-2020-N-0026-0001 FDA None FDA-2020-N-0026 Issuance of Priority Review Voucher; Rare Pediatric Disease Product Notice Announcement 2020-01-23T05:00:00Z 2020 1 2020-01-23T05:00:00Z   2020-01-23T13:49:52Z 2020-01059 0 0 09000064842de5ef

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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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