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

9 rows where docket_id = "FDA-2009-D-0461" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, comment_end_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-D-0461-0100 FDA None FDA-2009-D-0461 Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability Notice Notice of Data Availability 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z   2023-01-05T13:06:16Z 2022-28602 0 0 090000648558aa6c
FDA-2009-D-0461-0101 FDA None FDA-2009-D-0461 Format and Content of a REMS Document Guidance for Industry Other Guidance 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z   2024-11-12T23:50:24Z   1 0 090000648558b3d9
FDA-2009-D-0461-0071 FDA None FDA-2009-D-0461 Format and Content of a REMS Document Guidance for Industry Other Guidance 2017-10-12T04:00:00Z 2017 10 2017-10-12T04:00:00Z   2024-11-07T01:18:09Z   1 0 0900006482bc1d70
FDA-2009-D-0461-0070 FDA None FDA-2009-D-0461 Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability Notice Notice of Availability 2017-10-12T04:00:00Z 2017 10 2017-10-12T04:00:00Z 2017-12-12T04:59:59Z 2017-12-12T02:03:04Z 2017-22050 0 0 0900006482bc0c32
FDA-2009-D-0461-0068 FDA None FDA-2009-D-0461 Novartis Pharmaceuticals Corporation (NPC) - Supplement Other SUP-Supplement 2010-10-21T04:00:00Z 2010 10 2010-10-21T04:00:00Z   2013-07-27T23:35:13Z   0 0 0900006480b73fde
FDA-2009-D-0461-0040 FDA None FDA-2009-D-0461 Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period Notice NM-Notice of Meeting 2010-06-17T04:00:00Z 2010 6 2010-06-17T04:00:00Z 2010-09-01T03:59:59Z 2010-10-29T01:10:10Z 2010-14547 0 0 0900006480b041b2
FDA-2009-D-0461-0015 FDA None FDA-2009-D-0461 See FDA-2009-D-0461-0026 Supporting & Related Material   2009-12-30T00:00:00Z 2009 12     2013-07-29T17:10:22Z   0 1 0900006480a70e27
FDA-2009-D-0461-0002 FDA None FDA-2009-D-0461 Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications Other GDL-Guidance (Supporting and Related Materials) 2009-10-01T04:00:00Z 2009 10 2009-10-01T04:00:00Z 2009-12-31T04:59:59Z 2009-10-01T18:24:50Z   0 0 0900006480a35aeb
FDA-2009-D-0461-0001 FDA None FDA-2009-D-0461 Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies, REMS Assessments, and Proposed REMS Modifications Notice NAD-Notice of Availability of Data 2009-10-01T04:00:00Z 2009 10 2009-10-01T04:00:00Z 2009-12-31T04:59:59Z 2009-10-01T17:52:42Z E9-23616 0 0 0900006480a34d5a

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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;