documents

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

16 rows where docket_id = "FDA-2001-D-0219" sorted by posted_date descending

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posted_year 4

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2001-D-0219-0015 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice Notice of Availability 2024-02-13T05:00:00Z 2024 2     2024-02-13T14:42:27Z 2024-02849 0 0 0900006486404168
FDA-2001-D-0219-0016 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Use of Data Monitoring Committees in Clinical Trials; Guidance for Industry; Draft Guidance Other Guidance 2024-02-13T05:00:00Z 2024 2 2024-02-13T05:00:00Z 2024-04-16T03:59:59Z 2025-06-06T09:00:07Z   1 0 0900006486404548
FDA-2001-D-0219-0014 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab E - Tab E-Guidance for Industry, ICR E6, Good Clinica1 Practice: Consolidated Guidance, April 1996 [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T20:08:54Z   0 0 09000064804e4eb3
FDA-2001-D-0219-0013 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab D - Guidance for Industry, ICH E9, Statistical Principles forClinical Trials, September 1998 [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T20:08:52Z   0 0 09000064804e4eac
FDA-2001-D-0219-0010 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial Monitoring Committees, November 2201 - Draft Guidance Supporting & Related Material GDL-Guidance 2010-05-10T04:00:00Z 2010 5     2010-05-10T18:54:00Z   0 0 09000064804e4dee
FDA-2001-D-0219-0011 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 List of References [Guidance for Clinical Trial SponsorsEstablishment & Operation of Clinical Trial Monitoring Committees 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T19:48:22Z   0 0 09000064804e4ea1
FDA-2001-D-0219-0012 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab C - DHHS, Finaneial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection May 5, 2004. [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T19:45:19Z   0 0 09000064804e4ea3
FDA-2001-D-0219-0009 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees Notice NAL-Notice of Approval 2006-07-31T04:00:00Z 2006 7 2006-07-28T04:00:00Z   2010-05-10T16:54:40Z   0 0 09000064804e4ed0
FDA-2001-D-0219-0007 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Supporting Statement Supporting & Related Material SS-Supporting Statement 2006-07-31T04:00:00Z 2006 7     2008-04-25T02:28:20Z   0 0 09000064804e4ecb
FDA-2001-D-0219-0008 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Supporting Statement Supporting & Related Material SS-Supporting Statement 2006-07-31T04:00:00Z 2006 7     2008-04-25T02:28:19Z   0 0 09000064804e4ece
FDA-2001-D-0219-0005 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability Notice NAD-Notice of Availability of Data 2006-03-28T05:00:00Z 2006 3 2006-03-27T05:00:00Z   2010-05-10T16:50:29Z   0 0 09000064804e4ec0
FDA-2001-D-0219-0006 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006 Supporting & Related Material GDL-Guidance 2006-03-28T05:00:00Z 2006 3     2010-05-10T20:21:50Z   0 0 09000064804e4ec4
FDA-2001-D-0219-0003 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committee December 2005 - Draft Guidance Supporting & Related Material GDL-Guidance 2006-01-10T05:00:00Z 2006 1     2010-05-10T18:57:16Z   0 0 09000064804e4e9c
FDA-2001-D-0219-0004 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Agency Information Collection Activities; Submission for Office Notice N-Notice 2006-01-10T05:00:00Z 2006 1     2010-05-10T16:43:43Z   0 0 09000064804e4e9e
FDA-2001-D-0219-0002 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability Notice NAD-Notice of Availability of Data 2001-11-20T05:00:00Z 2001 11 2001-11-19T05:00:00Z 2002-02-20T04:59:59Z 2010-05-10T16:34:55Z   0 0 09000064804e4e02
FDA-2001-D-0219-0001 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Draft FDA Guidance on the Estabtishment and Operation of Clinical Trial Data Monitoring Committees; Public Meeting Notice NM-Notice of Meeting 2001-11-05T05:00:00Z 2001 11     2010-05-10T16:33:19Z   0 0 09000064804e4d7b

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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);