documents
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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Suggested facets: subtype, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;