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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

4 rows where docket_id = "FDA-2026-N-0005" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 3
  • Notice 1

posted_year 1

  • 2026 4

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-N-0005-0003 FDA Public Seminar FDA-2026-N-0005 Reference 2 - Kalaria SN, TR Farchione, R Uppoor, M Mehta, Y Wang, and H Zhu, 2021, Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder, Journal of Clinical Pharmacology, 61: S117–S124, doi: 10.1002/jcph.1836. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:12Z   0 0 09000064b92d59a0
FDA-2026-N-0005-0004 FDA Public Seminar FDA-2026-N-0005 Reference 3 - Kalaria SN, TR Farchione, MV Mathis, M Gopalakrishnan, I Younis, R Uppoor, M Mehta, Y Wang, and H Zhu, 2020, Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia, Journal of Clinical Pharmacology, 60(7): 848–859, doi: 10.1002/jcph.1580. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:15Z   0 0 09000064b92d59a1
FDA-2026-N-0005-0001 FDA Public Seminar FDA-2026-N-0005 Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information Notice Requests for Information (RFI) 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z 2026-07-14T03:59:59Z 2026-05-13T17:06:21Z 2026-09533 1 0 09000064b92d48f3
FDA-2026-N-0005-0002 FDA Public Seminar FDA-2026-N-0005 Reference 1 - Chen J, J Florian, W Carter, RD Fleischer, TS Hammerstrom, PR Jadhav, W Zeng, J Murray, and D Birnkrant, 2013, Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies, Gastroenterology, 144(7):1450–1455.e2, epub ahead of print March 5, 2013, doi: 10.1053/j.gastro.2013.02.039. Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:07:08Z   0 0 09000064b92d599f

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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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